## Protocol Section
### Identification Module
**NCT ID:** NCT03131479

**Brief Title:** Study of PK/PD, Safety and Tolerability of LIK066 in Patients With Decreased Renal Function.

**Official Title:** An Open-label, Parallel-group Study to Assess the Effect of LIK066 on Urinary Glucose Excretion, Pharmacokinetics, Safety and Tolerability Following Multiple Dose Administration in Patients With Decreased Renal Function Compared to Subjects With Normal Renal Function

#### Organization Study ID Info
**ID:** CLIK066B2202
#### Organization
**Class:** INDUSTRY
**Full Name:** Novartis
#### Secondary ID Infos
**ID:** 2016-004770-18
**Type:** EUDRACT_NUMBER
### Status Module
#### Completion Date
**Date:** 2018-01-16

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-01-05

**Type:** ACTUAL

**Last Update Submit Date:** 2020-12-09

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2018-01-16

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2019-02-06

**Type:** ACTUAL

**Results First Submit Date:** 2019-01-11

**Results First Submit QC Date:** 2019-01-11

#### Start Date
**Date:** 2017-04-28

**Type:** ACTUAL

**Status Verified Date:** 2019-06

#### Study First Post Date
**Date:** 2017-04-27
**Type:** ACTUAL
**Study First Submit Date:** 2017-04-17
**Study First Submit QC Date:** 2017-04-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Novartis Pharmaceuticals

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this trial was to evaluate whether the study drug, LIK066, causes glucose excretion in urine in patients with varying degrees of decreased kidney function and in subjects with normal kidney function. Blood samples were collected to measure the concentrations of LIK066 and to study the pharmacokinetics of LIK066. Pharmacokinetics is meant to study how LIK066 is absorbed, distributed and eliminated, in other words what the body does to the drug. The results of this study may be used to help determine whether LIK066 can be used to treat people with reduced kidney function and the proper dosing regimen.

### Conditions Module

**Conditions:**

- Renal Impairment

**Keywords:**

- renal function

- sodium-glucose co-transporter

- pharmacokinetics

- decreased renal function

- decreased kidney function

- kidney disease

- urinary glucose excretion

- UGE

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 53

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients with mild renal impairment (Group 1) received LIK066 50 mg qd before breakfast for 7 days.

**Intervention Names:**

- Drug: LIK066

**Label:** Mild

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Patients with moderate renal impairment grade A (Group 2) received LIK066 50 mg qd before breakfast for 7 days.

**Intervention Names:**

- Drug: LIK066

**Label:** Moderate A

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Patients with moderate renal impairment grade B (Group 3) received LIK066 50 mg qd before breakfast for 7 days.

**Intervention Names:**

- Drug: LIK066

**Label:** Moderate B

**Type:** EXPERIMENTAL

#### Arm Group 4

**Description:** Patients with severe renal impairment (Group 4) received LIK066 50 mg qd before breakfast for 7 days.

**Intervention Names:**

- Drug: LIK066

**Label:** Severe

**Type:** EXPERIMENTAL

#### Arm Group 5

**Description:** Patients with normal renal function (Group 5) received LIK066 50 mg qd before breakfast for 7 days.

**Intervention Names:**

- Drug: LIK066

**Label:** Normal

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Mild

- Moderate A

- Moderate B

- Normal

- Severe

**Description:** LIK066 50 mg tablets taken orally once daily before breakfast for 7 days.

**Name:** LIK066

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Urine was collected over 24 h to measure Urinary Glucose Excretion (UGE) at baseline (Day -1), following a single dose (Day 1) and at the end of the 7-day treatment (Day 7) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function.

**Measure:** Change From Baseline in 24-hour Urinary Glucose Excretion (UGE) on Day 7

**Time Frame:** Baseline , Day 7

**Description:** Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations.

Cmax was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. Only descriptive analysis done.

**Measure:** Maximum Observed Plasma Concentration (Cmax) for LIK066

**Time Frame:** Day 1 and Day 7 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)

**Description:** Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations.

Tmax was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. Only descriptive analysis done.

**Measure:** Time to Reach the Maximum Plasma Concentration (Tmax) for LIK066

**Time Frame:** Day 1 and Day 7 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)

**Description:** Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations.

AUCtau was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. Only descriptive analysis done.

**Measure:** Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) for LIK066

**Time Frame:** Day 1 and Day 7 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)

**Description:** Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations.

AUClast was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. AUClast is similar to AUCtau on Day 1 since the Tlast for Day 1 = 24hrs (tau = 24hrs); therefore AUClast is not reported for Day1, it is however reported for Day 7 since the Tlast is different from 24 hours. Only descriptive analysis done.

**Measure:** Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) for LIK066 on Day 7

**Time Frame:** Day 7 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)

**Description:** Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations.

AUCinf was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. AUCinf is a single dose parameter and therefore is presented on Day 1 only, after the first dose of LIK066. Only descriptive analysis done.

**Measure:** Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) for LIK066 on Day 1

**Time Frame:** Day 1 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)

**Description:** Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations.

T1/2 was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. T1/2 is only reported at Day 7 only, since there was sampling out to \~5 half-lives after the Day 7 dose of LIK066. Only descriptive analysis done.

**Measure:** Terminal Elimination Half-life (T1/2) for LIK066 on Day 7

**Time Frame:** Day 7 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)

**Description:** Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations.

CL/F was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. Since Day 7 represented steady state of LIK066 in the study, the appropriately calculated steady-state clearance parameter computed was CLss/F and was presented. Only descriptive analysis done.

**Measure:** Apparent Systemic (or Total Body) Clearance From Plasma Following Extravascular Administration (CL/F) for LIK066 on Day 1

**Time Frame:** Day 1 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)

**Description:** Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations.

Vz/F was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. Only descriptive analysis done.

**Measure:** Apparent Volume of Distribution During the Terminal Elimination Phase Following Extravascular Administration (Vz/F) for LIK066 on Day 1

**Time Frame:** Day 1 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)

**Description:** Urine PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations.

CLr was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. Only descriptive analysis done.

**Measure:** Renal Clearance From Plasma (CLr) for LIK066

**Time Frame:** Day 1 and Day 7 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Written informed consent must be obtained before any assessment is performed.
* Male and female subjects age 18-78 years, inclusive, with controlled health condition as determined by past medical history, physical examination, electrocardiogram and laboratory test at screening.
* patients with Type 2 diabetes, HbA1c \<10% at screening.
* Body mass index (BMI) ≤ 50 kg/m\^2 at screening.

Exclusion Criteria:

* Patients with Type 1 diabetes
* Evidence of clinically significant liver function test: ALT, AST, gamma-GT, alkaline phosphatase \>3 X ULN; serum bilirubin \> 1.5 X ULN.
* Patients undergoing any method of dialysis
* clinically significant GI disorder related to malabsorption or that may affect drug or glucose absorption.
* subjects who experienced ketoacidosis, lactic acidosis or hyperosmolar coma within 6 months of screening visit.

**Maximum Age:** 78 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Orlando

**Country:** United States

**Facility:** Novartis Investigative Site

**State:** Florida

**Zip:** 32809

#### Overall Officials

**Official 1:**

**Affiliation:** Novartis Pharmaceuticals

**Name:** Novartis Pharmaceuticals

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**Description:** Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

**IPD Sharing:** YES

**URL:** https://www.clinicalstudydatarequest.com

### References Module

#### See Also Links

**Label:** A Plain Language Trial Summary is available on novartisclinicatrials.com

**URL:** https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=371

## Document Section

### Large Document Module

#### Large Docs

- Date: 2017-01-11

- Filename: Prot_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: False

- Label: Study Protocol

- Size: 494778

- Type Abbrev: Prot

- Upload Date: 2019-01-11T04:15

- Date: 2018-02-15

- Filename: SAP_001.pdf

- Has ICF: False

- Has Protocol: False

- Has SAP: True

- Label: Statistical Analysis Plan

- Size: 302705

- Type Abbrev: SAP

- Upload Date: 2019-01-11T04:15

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007674

- Term: Kidney Diseases

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M10698

- Name: Kidney Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M26718

- Name: Renal Insufficiency

- Relevance: HIGH

- As Found: Renal Impairment

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000051437

- Term: Renal Insufficiency

### Intervention Browse Module - Ancestors

- ID: D000077203

- Term: Sodium-Glucose Transporter 2 Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000007004

- Term: Hypoglycemic Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: Hypo

- Name: Hypoglycemic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M342197

- Name: Licogliflozin

- Relevance: HIGH

- As Found: Extrusion

- ID: M1691

- Name: Sodium-Glucose Transporter 2 Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M10054

- Name: Hypoglycemic Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000709456

- Term: Licogliflozin

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Normal

**Deaths Num At Risk:** 10

**Description:** Patients with normal renal function (Group 5) received LIK066 50 mg qd before breakfast for 7 days.

**ID:** EG000

**Other Num Affected:** 9

**Other Num at Risk:** 10

**Serious Number At Risk:** 10

**Title:** Normal

**Group ID:** EG001

**Title:** Mild

**Deaths Num At Risk:** 10

**Description:** Patients with mild renal impairment (Group 1) received LIK066 50 mg qd before breakfast for 7 days.

**ID:** EG001

**Other Num Affected:** 10

**Other Num at Risk:** 10

**Serious Number At Risk:** 10

**Title:** Mild

**Group ID:** EG002

**Title:** Moderate A

**Deaths Num At Risk:** 10

**Description:** Patients with moderate renal impairment grade A (Group 2) received LIK066 50 mg qd before breakfast for 7 days.

**ID:** EG002

**Other Num Affected:** 10

**Other Num at Risk:** 10

**Serious Number At Risk:** 10

**Title:** Moderate A

**Group ID:** EG003

**Title:** Moderate B

**Deaths Num At Risk:** 11

**Description:** Patients with moderate renal impairment grade B (Group 3) received LIK066 50 mg qd before breakfast for 7 days.

**ID:** EG003

**Other Num Affected:** 11

**Other Num at Risk:** 11

**Serious Number Affected:** 1

**Serious Number At Risk:** 11

**Title:** Moderate B

**Group ID:** EG004

**Title:** Severe

**Deaths Num At Risk:** 12

**Description:** Patients with severe renal impairment (Group 4) received LIK066 50 mg qd before breakfast for 7 days.

**ID:** EG004

**Other Num Affected:** 11

**Other Num at Risk:** 12

**Serious Number Affected:** 1

**Serious Number At Risk:** 12

**Title:** Severe

**Frequency Threshold:** 1

#### Other Events

**Term:** Abdominal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (20.0)

**Term:** Diarrhoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (20.0)

**Term:** Flatulence

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (20.0)

**Term:** Nausea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (20.0)

**Term:** Vomiting

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (20.0)

**Term:** Hypoglycaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (20.0)

**Term:** Metabolic acidosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (20.0)

**Term:** Arthralgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (20.0)

**Term:** Muscle spasms

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (20.0)

**Term:** Dizziness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (20.0)

**Term:** Headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (20.0)

**Term:** Tremor

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (20.0)

**Term:** Vaginal haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** MedDRA (20.0)

#### Serious Events

**Term:** Acute left ventricular failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 10

**Group ID:** EG001

**Num At Risk:** 10

**Group ID:** EG002

**Num At Risk:** 10

**Group ID:** EG003

**Num At Risk:** 11

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 12

**Term:** Acute myocardial infarction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (20.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 10

**Group ID:** EG001

**Num At Risk:** 10

**Group ID:** EG002

**Num At Risk:** 10

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 11

**Group ID:** EG004

**Num At Risk:** 12

**Time Frame:** Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 10

**Group ID:** BG001

**Value:** 10

**Group ID:** BG002

**Value:** 11

**Group ID:** BG003

**Value:** 12

**Group ID:** BG004

**Value:** 10

**Group ID:** BG005

**Value:** 53

**Units:** Participants

### Group

**ID:** BG000

**Title:** Mild

**Description:** Patients with mild renal impairment (Group 1) received LIK066 50 mg qd before breakfast for 7 days.

### Group

**ID:** BG001

**Title:** Moderate A

**Description:** Patients with moderate renal impairment grade A (Group 2) received LIK066 50 mg qd before breakfast for 7 days.

### Group

**ID:** BG002

**Title:** Moderate B

**Description:** Patients with moderate renal impairment grade B (Group 3) received LIK066 50 mg qd before breakfast for 7 days.

### Group

**ID:** BG003

**Title:** Severe

**Description:** Patients with severe renal impairment (Group 4) received LIK066 50 mg qd before breakfast for 7 days.

### Group

**ID:** BG004

**Title:** Normal

**Description:** Patients with normal renal function (Group 5) received LIK066 50 mg qd before breakfast for 7 days.

### Group

**ID:** BG005

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 9.03

**Value:** 65.4

#### Measurement

**Group ID:** BG001

**Spread:** 8.10

**Value:** 66.3

#### Measurement

**Group ID:** BG002

**Spread:** 9.10

**Value:** 65.8

#### Measurement

**Group ID:** BG003

**Spread:** 12.66

**Value:** 63.3

#### Measurement

**Group ID:** BG004

**Spread:** 8.17

**Value:** 59.3

#### Measurement

**Group ID:** BG005

**Spread:** 9.66

**Value:** 64.0

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 6

#### Measurement

**Group ID:** BG001

**Value:** 5

#### Measurement

**Group ID:** BG002

**Value:** 8

#### Measurement

**Group ID:** BG003

**Value:** 3

#### Measurement

**Group ID:** BG004

**Value:** 6

#### Measurement

**Group ID:** BG005

**Value:** 28

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 4

#### Measurement

**Group ID:** BG001

**Value:** 5

#### Measurement

**Group ID:** BG002

**Value:** 3

#### Measurement

**Group ID:** BG003

**Value:** 9

#### Measurement

**Group ID:** BG004

**Value:** 4

#### Measurement

**Group ID:** BG005

**Value:** 25

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

#### Measurement

**Group ID:** BG004

**Value:** 0

#### Measurement

**Group ID:** BG005

**Value:** 0

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

#### Measurement

**Group ID:** BG004

**Value:** 0

#### Measurement

**Group ID:** BG005

**Value:** 0

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

#### Measurement

**Group ID:** BG004

**Value:** 1

#### Measurement

**Group ID:** BG005

**Value:** 1

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 3

#### Measurement

**Group ID:** BG003

**Value:** 3

#### Measurement

**Group ID:** BG004

**Value:** 4

#### Measurement

**Group ID:** BG005

**Value:** 14

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 7

#### Measurement

**Group ID:** BG001

**Value:** 9

#### Measurement

**Group ID:** BG002

**Value:** 8

#### Measurement

**Group ID:** BG003

**Value:** 9

#### Measurement

**Group ID:** BG004

**Value:** 5

#### Measurement

**Group ID:** BG005

**Value:** 38

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

#### Measurement

**Group ID:** BG004

**Value:** 0

#### Measurement

**Group ID:** BG005

**Value:** 0

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

#### Measurement

**Group ID:** BG004

**Value:** 0

#### Measurement

**Group ID:** BG005

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 9.96

**Value:** 4.7

#### Measurement

**Group ID:** BG001

**Spread:** 6.27

**Value:** 2.9

#### Measurement

**Group ID:** BG002

**Spread:** 0.12

**Value:** 0.1

#### Measurement

**Group ID:** BG003

**Spread:** 0.77

**Value:** 0.3

#### Measurement

**Group ID:** BG004

**Spread:** 0.07

**Value:** 0.1

#### Measurement

**Group ID:** BG005

**Spread:** 5.25

**Value:** 1.5

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** Years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
### Measure 4
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** 24-hour Urinary glucose excretion (UGE)
**Unit of Measure:** gram (g)
## Results Section - More Information Module
### Certain Agreement
**Other Details:** The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Point of Contact
**Email:** Novartis.email@novartis.com
**Organization:** Novartis Pharmaceuticals
**Phone:** 862-778-8300
**Title:** Study Director
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** -19.88
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 1.45
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** Change from baseline was analyzed using a repeated measures model which included diabetic status, renal function, day and renal function\*day and diabetic status\*day as fixed factors and age, baseline body weight and baseline fasting plasma glucose as covariates.
**Non-Inferiority Type:** EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.154
**P-Value Comment:** 
**Parameter Type:** adjusted arithmetic mean difference
**Parameter Value:** -9.21
**Statistical Comment:** An unstructured variance-covariance structure was used. Baseline is defined to be the measurement collected on Day -1.
**Statistical Method:** Regression, Logistic
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -16.65
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 4.55
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** Change from baseline was analyzed using a repeated measures model which included diabetic status, renal function, day and renal function\*day and diabetic status\*day as fixed factors and age, baseline body weight and baseline fasting plasma glucose as covariates.
**Non-Inferiority Type:** EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.343
**P-Value Comment:** 
**Parameter Type:** adjusted arithmetic mean difference
**Parameter Value:** -6.05
**Statistical Comment:** 
**Statistical Method:** Regression, Logistic
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -31.79
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 4.55
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** Change from baseline was analyzed using a repeated measures model which included diabetic status, renal function, day and renal function\*day and diabetic status\*day as fixed factors and age, baseline body weight and baseline fasting plasma glucose as covariates.
**Non-Inferiority Type:** EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.001
**P-Value Comment:** 
**Parameter Type:** adjusted arithmetic mean difference
**Parameter Value:** -21.5
**Statistical Comment:** 
**Statistical Method:** Regression, Logistic
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -46.00
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -25.11
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** Change from baseline was analyzed using a repeated measures model which included diabetic status, renal function, day and renal function\*day and diabetic status\*day as fixed factors and age, baseline body weight and baseline fasting plasma glucose as covariates.
**Non-Inferiority Type:** EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.000
**P-Value Comment:** 
**Parameter Type:** adjusted arithmetic mean difference
**Parameter Value:** -35.6
**Statistical Comment:** 
**Statistical Method:** Regression, Logistic
**Tested Non-Inferiority:** 
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
### Outcome Measure 7
### Outcome Measure 8
### Outcome Measure 9
### Outcome Measure 10
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 21.93
- **Upper Limit:** 
- **Value:** 40.45
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 13.79
- **Upper Limit:** 
- **Value:** 31.87
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 19.51
- **Upper Limit:** 
- **Value:** 36.27
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 18.66
- **Upper Limit:** 
- **Value:** 19.88
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 3.75
- **Upper Limit:** 
- **Value:** 5.50
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 176
- **Upper Limit:** 
- **Value:** 565
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 176
- **Upper Limit:** 
- **Value:** 590
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 142
- **Upper Limit:** 
- **Value:** 492
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 147
- **Upper Limit:** 
- **Value:** 569
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 199
- **Upper Limit:** 
- **Value:** 650
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 10
- **Group ID:** OG001
- **Value:** 10
- **Group ID:** OG002
- **Value:** 10
- **Group ID:** OG003
- **Value:** 11
- **Group ID:** OG004
- **Value:** 12
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 250
- **Upper Limit:** 
- **Value:** 650
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 219
- **Upper Limit:** 
- **Value:** 678
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 243
- **Upper Limit:** 
- **Value:** 686
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 301
- **Upper Limit:** 
- **Value:** 743
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 268
- **Upper Limit:** 
- **Value:** 800
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 10
- **Group ID:** OG001
- **Value:** 10
- **Group ID:** OG002
- **Value:** 10
- **Group ID:** OG003
- **Value:** 10
- **Group ID:** OG004
- **Value:** 10
**Units:** Participants
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.500
- **Spread:** 
- **Upper Limit:** 4.03
- **Value:** 1.00
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.500
- **Spread:** 
- **Upper Limit:** 4.00
- **Value:** 1.00
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 1.00
- **Spread:** 
- **Upper Limit:** 8.00
- **Value:** 1.00
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 0.500
- **Spread:** 
- **Upper Limit:** 3.00
- **Value:** 1.00
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 0.500
- **Spread:** 
- **Upper Limit:** 4.00
- **Value:** 1.00
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 10
- **Group ID:** OG001
- **Value:** 10
- **Group ID:** OG002
- **Value:** 10
- **Group ID:** OG003
- **Value:** 11
- **Group ID:** OG004
- **Value:** 12
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.500
- **Spread:** 
- **Upper Limit:** 3.00
- **Value:** 1.00
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.500
- **Spread:** 
- **Upper Limit:** 4.00
- **Value:** 1.03
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 0.500
- **Spread:** 
- **Upper Limit:** 6.00
- **Value:** 1.00
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 0.500
- **Spread:** 
- **Upper Limit:** 2.00
- **Value:** 1.00
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 0.500
- **Spread:** 
- **Upper Limit:** 2.00
- **Value:** 1.00
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 10
- **Group ID:** OG001
- **Value:** 10
- **Group ID:** OG002
- **Value:** 10
- **Group ID:** OG003
- **Value:** 10
- **Group ID:** OG004
- **Value:** 10
**Units:** Participants
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 650
- **Upper Limit:** 
- **Value:** 2830
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 563
- **Upper Limit:** 
- **Value:** 3330
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 567
- **Upper Limit:** 
- **Value:** 3120
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 886
- **Upper Limit:** 
- **Value:** 3360
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 1040
- **Upper Limit:** 
- **Value:** 4150
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 10
- **Group ID:** OG001
- **Value:** 10
- **Group ID:** OG002
- **Value:** 9
- **Group ID:** OG003
- **Value:** 11
- **Group ID:** OG004
- **Value:** 12
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 790
- **Upper Limit:** 
- **Value:** 3440
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 981
- **Upper Limit:** 
- **Value:** 4170
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 1040
- **Upper Limit:** 
- **Value:** 4080
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 1240
- **Upper Limit:** 
- **Value:** 4510
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 2280
- **Upper Limit:** 
- **Value:** 6290
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 10
- **Group ID:** OG001
- **Value:** 10
- **Group ID:** OG002
- **Value:** 10
- **Group ID:** OG003
- **Value:** 10
- **Group ID:** OG004
- **Value:** 10
**Units:** Participants
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1090
- **Upper Limit:** 
- **Value:** 4190
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1540
- **Upper Limit:** 
- **Value:** 5280
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 1740
- **Upper Limit:** 
- **Value:** 5440
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 2160
- **Upper Limit:** 
- **Value:** 6410
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 3910
- **Upper Limit:** 
- **Value:** 9620
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 688
- **Upper Limit:** 
- **Value:** 310
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 649
- **Upper Limit:** 
- **Value:** 3610
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 551
- **Upper Limit:** 
- **Value:** 3440
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 1000
- **Upper Limit:** 
- **Value:** 3520
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 1480
- **Upper Limit:** 
- **Value:** 4450
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 20.3
- **Upper Limit:** 
- **Value:** 22.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 10.8
- **Upper Limit:** 
- **Value:** 21.8
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 9.25
- **Upper Limit:** 
- **Value:** 21.1
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 8.91
- **Upper Limit:** 
- **Value:** 20.9
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 9.52
- **Upper Limit:** 
- **Value:** 22.8
**Title:** 
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 4.20
- **Upper Limit:** 
- **Value:** 17.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.59
- **Upper Limit:** 
- **Value:** 14.3
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 2.55
- **Upper Limit:** 
- **Value:** 14.9
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 4.87
- **Upper Limit:** 
- **Value:** 15.4
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 4.53
- **Upper Limit:** 
- **Value:** 12.4
**Title:** 
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 59.4
- **Upper Limit:** 
- **Value:** 160
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 28.6
- **Upper Limit:** 
- **Value:** 140
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 79.9
- **Upper Limit:** 
- **Value:** 164
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 67.8
- **Upper Limit:** 
- **Value:** 176
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 50.5
- **Upper Limit:** 
- **Value:** 134
**Title:** 
#### Outcome Measure 10
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.179
- **Upper Limit:** 
- **Value:** 0.389
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.141
- **Upper Limit:** 
- **Value:** 0.348
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.114
- **Upper Limit:** 
- **Value:** 0.259
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 0.0919
- **Upper Limit:** 
- **Value:** 0.173
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 0.0237
- **Upper Limit:** 
- **Value:** 0.0522
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 10
- **Group ID:** OG001
- **Value:** 10
- **Group ID:** OG002
- **Value:** 9
- **Group ID:** OG003
- **Value:** 11
- **Group ID:** OG004
- **Value:** 12
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.275
- **Upper Limit:** 
- **Value:** 0.474
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.0815
- **Upper Limit:** 
- **Value:** 0.367
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.119
- **Upper Limit:** 
- **Value:** 0.294
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 0.0636
- **Upper Limit:** 
- **Value:** 0.174
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 0.0461
- **Upper Limit:** 
- **Value:** 0.0694
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 10
- **Group ID:** OG001
- **Value:** 10
- **Group ID:** OG002
- **Value:** 10
- **Group ID:** OG003
- **Value:** 10
- **Group ID:** OG004
- **Value:** 10
**Units:** Participants
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Urine was collected over 24 h to measure Urinary Glucose Excretion (UGE) at baseline (Day -1), following a single dose (Day 1) and at the end of the 7-day treatment (Day 7) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacodynamic Analysis Set (PD), which consisted of all participants with an observed PD value, was considered. Only patients with evaluable data at each time point were analyzed for that time point.
**Reporting Status:** POSTED
**Time Frame:** Baseline , Day 7
**Title:** Change From Baseline in 24-hour Urinary Glucose Excretion (UGE) on Day 7
**Type:** PRIMARY
**Unit of Measure:** gram (g)
##### Group
**Description:** Patients with normal renal function (Group 5) received LIK066 50 mg qd before breakfast for 7 days.
**ID:** OG000
**Title:** Normal
##### Group
**Description:** Patients with mild renal impairment (Group 1) received LIK066 50 mg qd before breakfast for 7 days.
**ID:** OG001
**Title:** Mild
##### Group
**Description:** Patients with moderate renal impairment grade A (Group 2) received LIK066 50 mg qd before breakfast for 7 days.
**ID:** OG002
**Title:** Moderate A
##### Group
**Description:** Patients with moderate renal impairment grade B (Group 3) received LIK066 50 mg qd before breakfast for 7 days.
**ID:** OG003
**Title:** Moderate B
##### Group
**Description:** Patients with severe renal impairment (Group 4) received LIK066 50 mg qd before breakfast for 7 days.
**ID:** OG004
**Title:** Severe
#### Outcome Measure 2
**Description:** Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations.

Cmax was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. Only descriptive analysis done.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic Analysis Set (PAS), which consisted of all participants with at least 1 valid PK concentration measurement, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done.
**Reporting Status:** POSTED
**Time Frame:** Day 1 and Day 7 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)
**Title:** Maximum Observed Plasma Concentration (Cmax) for LIK066
**Type:** PRIMARY
**Unit of Measure:** nanogram per milliliter (ng/mL)
##### Group
**Description:** Patients with normal renal function (Group 5) received LIK066 50 mg qd before breakfast for 7 days.
**ID:** OG000
**Title:** Normal
##### Group
**Description:** Patients with mild renal impairment (Group 1) received LIK066 50 mg qd before breakfast for 7 days.
**ID:** OG001
**Title:** Mild
##### Group
**Description:** Patients with moderate renal impairment grade A (Group 2) received LIK066 50 mg qd before breakfast for 7 days.
**ID:** OG002
**Title:** Moderate A
##### Group
**Description:** Patients with moderate renal impairment grade B (Group 3) received LIK066 50 mg qd before breakfast for 7 days.
**ID:** OG003
**Title:** Moderate B
##### Group
**Description:** Patients with severe renal impairment (Group 4) received LIK066 50 mg qd before breakfast for 7 days.
**ID:** OG004
**Title:** Severe
#### Outcome Measure 3
**Description:** Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations.

Tmax was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. Only descriptive analysis done.
**Dispersion Type:** Full Range
**Parameter Type:** MEDIAN
**Population Description:** Pharmacokinetic Analysis Set (PAS), which consisted of all participants with at least 1 valid PK concentration measurement, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done.
**Reporting Status:** POSTED
**Time Frame:** Day 1 and Day 7 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)
**Title:** Time to Reach the Maximum Plasma Concentration (Tmax) for LIK066
**Type:** PRIMARY
**Unit of Measure:** hour (hr)
##### Group
**Description:** Patients with normal renal function (Group 5) received LIK066 50 mg qd before breakfast for 7 days.
**ID:** OG000
**Title:** Normal
##### Group
**Description:** Patients with mild renal impairment (Group 1) received LIK066 50 mg qd before breakfast for 7 days.
**ID:** OG001
**Title:** Mild
##### Group
**Description:** Patients with moderate renal impairment grade A (Group 2) received LIK066 50 mg qd before breakfast for 7 days.
**ID:** OG002
**Title:** Moderate A
##### Group
**Description:** Patients with moderate renal impairment grade B (Group 3) received LIK066 50 mg qd before breakfast for 7 days.
**ID:** OG003
**Title:** Moderate B
##### Group
**Description:** Patients with severe renal impairment (Group 4) received LIK066 50 mg qd before breakfast for 7 days.
**ID:** OG004
**Title:** Severe
#### Outcome Measure 4
**Description:** Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations.

AUCtau was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. Only descriptive analysis done.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic Analysis Set (PAS), which consisted of all participants with at least 1 valid PK concentration measurement, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done.
**Reporting Status:** POSTED
**Time Frame:** Day 1 and Day 7 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)
**Title:** Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) for LIK066
**Type:** PRIMARY
**Unit of Measure:** hour*nanogram per milliliter (hr*ng/mL)
##### Group
**Description:** Patients with normal renal function (Group 5) received LIK066 50 mg qd before breakfast for 7 days.
**ID:** OG000
**Title:** Normal
##### Group
**Description:** Patients with mild renal impairment (Group 1) received LIK066 50 mg qd before breakfast for 7 days.
**ID:** OG001
**Title:** Mild
##### Group
**Description:** Patients with moderate renal impairment grade A (Group 2) received LIK066 50 mg qd before breakfast for 7 days.
**ID:** OG002
**Title:** Moderate A
##### Group
**Description:** Patients with moderate renal impairment grade B (Group 3) received LIK066 50 mg qd before breakfast for 7 days.
**ID:** OG003
**Title:** Moderate B
##### Group
**Description:** Patients with severe renal impairment (Group 4) received LIK066 50 mg qd before breakfast for 7 days.
**ID:** OG004
**Title:** Severe
#### Outcome Measure 5
**Description:** Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations.

AUClast was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. AUClast is similar to AUCtau on Day 1 since the Tlast for Day 1 = 24hrs (tau = 24hrs); therefore AUClast is not reported for Day1, it is however reported for Day 7 since the Tlast is different from 24 hours. Only descriptive analysis done.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic Analysis Set (PAS), which consisted of all participants with at least 1 valid PK concentration measurement, was considered. Only descriptive analysis done.
**Reporting Status:** POSTED
**Time Frame:** Day 7 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)
**Title:** Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) for LIK066 on Day 7
**Type:** PRIMARY
**Unit of Measure:** hour*nanogram per milliliter (hr*ng/mL)
##### Group
**Description:** Patients with normal renal function (Group 5) received LIK066 50 mg qd before breakfast for 7 days.
**ID:** OG000
**Title:** Normal
##### Group
**Description:** Patients with mild renal impairment (Group 1) received LIK066 50 mg qd before breakfast for 7 days.
**ID:** OG001
**Title:** Mild
##### Group
**Description:** Patients with moderate renal impairment grade A (Group 2) received LIK066 50 mg qd before breakfast for 7 days.
**ID:** OG002
**Title:** Moderate A
##### Group
**Description:** Patients with moderate renal impairment grade B (Group 3) received LIK066 50 mg qd before breakfast for 7 days.
**ID:** OG003
**Title:** Moderate B
##### Group
**Description:** Patients with severe renal impairment (Group 4) received LIK066 50 mg qd before breakfast for 7 days.
**ID:** OG004
**Title:** Severe
#### Outcome Measure 6
**Description:** Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations.

AUCinf was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. AUCinf is a single dose parameter and therefore is presented on Day 1 only, after the first dose of LIK066. Only descriptive analysis done.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic Analysis Set (PAS), which consisted of all participants with at least 1 valid PK concentration measurement, was considered. Only descriptive analysis done.
**Reporting Status:** POSTED
**Time Frame:** Day 1 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)
**Title:** Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) for LIK066 on Day 1
**Type:** PRIMARY
**Unit of Measure:** hour*nanogram per milliliter (hr*ng/mL)
##### Group
**Description:** Patients with normal renal function (Group 5) received LIK066 50 mg qd before breakfast for 7 days.
**ID:** OG000
**Title:** Normal
##### Group
**Description:** Patients with mild renal impairment (Group 1) received LIK066 50 mg qd before breakfast for 7 days.
**ID:** OG001
**Title:** Mild
##### Group
**Description:** Patients with moderate renal impairment grade A (Group 2) received LIK066 50 mg qd before breakfast for 7 days.
**ID:** OG002
**Title:** Moderate A
##### Group
**Description:** Patients with moderate renal impairment grade B (Group 3) received LIK066 50 mg qd before breakfast for 7 days.
**ID:** OG003
**Title:** Moderate B
##### Group
**Description:** Patients with severe renal impairment (Group 4) received LIK066 50 mg qd before breakfast for 7 days.
**ID:** OG004
**Title:** Severe
#### Outcome Measure 7
**Description:** Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations.

T1/2 was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. T1/2 is only reported at Day 7 only, since there was sampling out to \~5 half-lives after the Day 7 dose of LIK066. Only descriptive analysis done.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic Analysis Set (PAS), which consisted of all participants with at least 1 valid PK concentration measurement, was considered. Only descriptive analysis done.
**Reporting Status:** POSTED
**Time Frame:** Day 7 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)
**Title:** Terminal Elimination Half-life (T1/2) for LIK066 on Day 7
**Type:** PRIMARY
**Unit of Measure:** hour (hr)
##### Group
**Description:** Patients with normal renal function (Group 5) received LIK066 50 mg qd before breakfast for 7 days.
**ID:** OG000
**Title:** Normal
##### Group
**Description:** Patients with mild renal impairment (Group 1) received LIK066 50 mg qd before breakfast for 7 days.
**ID:** OG001
**Title:** Mild
##### Group
**Description:** Patients with moderate renal impairment grade A (Group 2) received LIK066 50 mg qd before breakfast for 7 days.
**ID:** OG002
**Title:** Moderate A
##### Group
**Description:** Patients with moderate renal impairment grade B (Group 3) received LIK066 50 mg qd before breakfast for 7 days.
**ID:** OG003
**Title:** Moderate B
##### Group
**Description:** Patients with severe renal impairment (Group 4) received LIK066 50 mg qd before breakfast for 7 days.
**ID:** OG004
**Title:** Severe
#### Outcome Measure 8
**Description:** Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations.

CL/F was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. Since Day 7 represented steady state of LIK066 in the study, the appropriately calculated steady-state clearance parameter computed was CLss/F and was presented. Only descriptive analysis done.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic Analysis Set (PAS), which consisted of all participants with at least 1 valid PK concentration measurement, was considered. Only descriptive analysis done.
**Reporting Status:** POSTED
**Time Frame:** Day 1 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)
**Title:** Apparent Systemic (or Total Body) Clearance From Plasma Following Extravascular Administration (CL/F) for LIK066 on Day 1
**Type:** PRIMARY
**Unit of Measure:** Liter per hour (L/h)
##### Group
**Description:** Patients with normal renal function (Group 5) received LIK066 50 mg qd before breakfast for 7 days.
**ID:** OG000
**Title:** Normal
##### Group
**Description:** Patients with mild renal impairment (Group 1) received LIK066 50 mg qd before breakfast for 7 days.
**ID:** OG001
**Title:** Mild
##### Group
**Description:** Patients with moderate renal impairment grade A (Group 2) received LIK066 50 mg qd before breakfast for 7 days.
**ID:** OG002
**Title:** Moderate A
##### Group
**Description:** Patients with moderate renal impairment grade B (Group 3) received LIK066 50 mg qd before breakfast for 7 days.
**ID:** OG003
**Title:** Moderate B
##### Group
**Description:** Patients with severe renal impairment (Group 4) received LIK066 50 mg qd before breakfast for 7 days.
**ID:** OG004
**Title:** Severe
#### Outcome Measure 9
**Description:** Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations.

Vz/F was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. Only descriptive analysis done.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic Analysis Set (PAS), which consisted of all participants with at least 1 valid PK concentration measurement, was considered. Only descriptive analysis done.
**Reporting Status:** POSTED
**Time Frame:** Day 1 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)
**Title:** Apparent Volume of Distribution During the Terminal Elimination Phase Following Extravascular Administration (Vz/F) for LIK066 on Day 1
**Type:** PRIMARY
**Unit of Measure:** Liter (L)
##### Group
**Description:** Patients with normal renal function (Group 5) received LIK066 50 mg qd before breakfast for 7 days.
**ID:** OG000
**Title:** Normal
##### Group
**Description:** Patients with mild renal impairment (Group 1) received LIK066 50 mg qd before breakfast for 7 days.
**ID:** OG001
**Title:** Mild
##### Group
**Description:** Patients with moderate renal impairment grade A (Group 2) received LIK066 50 mg qd before breakfast for 7 days.
**ID:** OG002
**Title:** Moderate A
##### Group
**Description:** Patients with moderate renal impairment grade B (Group 3) received LIK066 50 mg qd before breakfast for 7 days.
**ID:** OG003
**Title:** Moderate B
##### Group
**Description:** Patients with severe renal impairment (Group 4) received LIK066 50 mg qd before breakfast for 7 days.
**ID:** OG004
**Title:** Severe
#### Outcome Measure 10
**Description:** Urine PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations.

CLr was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. Only descriptive analysis done.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic Analysis Set (PAS), which consisted of all participants with at least 1 valid PK concentration measurement, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done.
**Reporting Status:** POSTED
**Time Frame:** Day 1 and Day 7 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)
**Title:** Renal Clearance From Plasma (CLr) for LIK066
**Type:** PRIMARY
**Unit of Measure:** Liter per hour (L/hr)
##### Group
**Description:** Patients with normal renal function (Group 5) received LIK066 50 mg qd before breakfast for 7 days.
**ID:** OG000
**Title:** Normal
##### Group
**Description:** Patients with mild renal impairment (Group 1) received LIK066 50 mg qd before breakfast for 7 days.
**ID:** OG001
**Title:** Mild
##### Group
**Description:** Patients with moderate renal impairment grade A (Group 2) received LIK066 50 mg qd before breakfast for 7 days.
**ID:** OG002
**Title:** Moderate A
##### Group
**Description:** Patients with moderate renal impairment grade B (Group 3) received LIK066 50 mg qd before breakfast for 7 days.
**ID:** OG003
**Title:** Moderate B
##### Group
**Description:** Patients with severe renal impairment (Group 4) received LIK066 50 mg qd before breakfast for 7 days.
**ID:** OG004
**Title:** Severe
### Participant Flow Module
#### Group
**Description:** Patients with mild renal impairment (Group 1) received LIK066 50 mg qd before breakfast for 7 days.
**ID:** FG000
**Title:** Mild
#### Group
**Description:** Patients with moderate renal impairment grade A (Group 2) received LIK066 50 mg qd before breakfast for 7 days.
**ID:** FG001
**Title:** Moderate A
#### Group
**Description:** Patients with moderate renal impairment grade B (Group 3) received LIK066 50 mg qd before breakfast for 7 days.
**ID:** FG002
**Title:** Moderate B
#### Group
**Description:** Patients with severe renal impairment (Group 4) received LIK066 50 mg qd before breakfast for 7 days.
**ID:** FG003
**Title:** Severe
#### Group
**Description:** Patients with normal renal function (Group 5) received LIK066 50 mg qd before breakfast for 7 days.
**ID:** FG004
**Title:** Normal
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 1
###### Reason
**Group ID:** FG003
**Number of Subjects:** 1
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
##### Withdraw
**Type:** Subject/Guardian Decision
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 1
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 10
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 10
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 11
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 12
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 10
##### Milestone
**Type:** Safety Analysis Set (SS)
**Comment:** All subjects that received study drug
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 10
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 10
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 11
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 12
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 10
##### Milestone
**Type:** Pharmacokinetic Analysis Set (PAS)
**Comment:** At least one dose of study drug and had at least 1 valid PK concentration measurement
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 10
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 10
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 11
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 12
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 10
##### Milestone
**Type:** Pharcodynamic Analysis Set (PD)
**Comment:** At least one dose of study drug and had at least 1 valid post baseline PD
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 10
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 10
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 11
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 12
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 10
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 10
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 10
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 10
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 10
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 10
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 1
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 2
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 0
**Recruitment Details:** This study was conducted at 1 centers in the United States.
**Has Results:** True