## Protocol Section
### Identification Module
**NCT ID:** NCT01744379

**Brief Title:** Single and Multiple Dose Study in Japanese

**Official Title:** A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of Lesinurad in Healthy Male Japanese Subjects

#### Organization Study ID Info
**ID:** RDEA594-125
#### Organization
**Class:** INDUSTRY
**Full Name:** Ardea Biosciences, Inc.
### Status Module
#### Completion Date
**Date:** 2013-05

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2013-06-19

**Type:** ESTIMATED

**Last Update Submit Date:** 2013-06-18

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2013-03

**Type:** ACTUAL

#### Start Date
**Date:** 2012-12

**Status Verified Date:** 2013-06

#### Study First Post Date
**Date:** 2012-12-06
**Type:** ESTIMATED
**Study First Submit Date:** 2012-11-29
**Study First Submit QC Date:** 2012-12-05
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Ardea Biosciences, Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This study will explore the safety, tolerability, and serum uric acid lowering effect of lesinurad in healthy Japanese males to allow comparison with the Western population.

**Detailed Description:** While there is extensive clinical experience with lesinurad in the Western population, it is recognized that both intrinsic and extrinsic factors may impact the PK, PD, safety, and dose response in different ethnic populations. The purpose of this study is to explore the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) of single and multiple doses of lesinurad in healthy Japanese males, and to allow comparison of these parameters with the Western population.

### Conditions Module

**Conditions:**

- Gout

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 40

**Type:** ACTUAL

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 200 mg lesinurad or placebo fasted and fed

**Intervention Names:**

- Drug: Lesinurad

- Drug: Placebo

**Label:** 200 mg lesinurad

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 400 mg lesinurad or placebo fasted and fed

**Intervention Names:**

- Drug: Lesinurad

- Drug: Placebo

**Label:** 400 mg lesinurad

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** 100 mg lesinurad or placebo fasted and fed

**Intervention Names:**

- Drug: Lesinurad

- Drug: Placebo

**Label:** 100 mg lesinurad

**Type:** EXPERIMENTAL

#### Arm Group 4

**Description:** 50 mg lesinurad or placebo fasted and fed

**Intervention Names:**

- Drug: Lesinurad

- Drug: Placebo

**Label:** 50 mg lesinurad

**Type:** EXPERIMENTAL

#### Arm Group 5

**Description:** 600 mg lesinurad or placebo fasted and fed

**Intervention Names:**

- Drug: Lesinurad

- Drug: Placebo

**Label:** 600 mg lesinurad

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 100 mg lesinurad

- 200 mg lesinurad

- 400 mg lesinurad

- 50 mg lesinurad

- 600 mg lesinurad

**Name:** Lesinurad

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- 100 mg lesinurad

- 200 mg lesinurad

- 400 mg lesinurad

- 50 mg lesinurad

- 600 mg lesinurad

**Name:** Placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Incidence of Adverse Events and Changes in Laboratory Parameters

**Time Frame:** 5 to 6 weeks

**Description:** AUC: area under the plasma concentration time curve from zero to 24 hours post dose and from zero to infinity; tmax: time to maximum plasma concentration; cmax: maximum observed plasma concentration t1/2: terminal elimination half life

**Measure:** Pharmacokinetic (PK) profile of lesinurad from plasma and urine in terms of AUC, tmax, cmax and t1/2.

**Time Frame:** Day -1 through 12

**Measure:** Pharmacodynamic (PD) profile of lesinurad from serum and urine in terms of sUA concentration, renal clearance, urine uric acid excretion, and fractional excretion.

**Time Frame:** Day 1 through 12

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Able to understand the study procedures, the risks involved and willing to provide written Informed Consent before the first study related activity.
* Healthy adult subjects born in Japan
* All laboratory parameters should be within normal limits or considered not clinically significant by the investigator.
* Screening serum uric acid level \>= 4.5 mg/dL.
* Subjects must be free of any clinically significant disease that requires a physician's care and/or would interfere with study evaluations or procedures.
* Subject does not have clinically relevant abnormalities in blood pressure, heart rate, body temperature, and respiratory rate, as per the Investigator's judgment.

Exclusion Criteria:

* Positive serology to Human Immunodeficiency Virus (HIV-1 and HIV-2).
* Positive test for active Hepatitis B or Hepatitis C infection.
* History of kidney stones.
* Undergone major surgery within 3 months of Day 1.
* Subject has received the last dose of an investigational drug (or treatment with a medical device) within 30 days or 5 half-lives (whichever is longer) of the investigational drug prior to Day 1 or are currently participating in another study of an investigational drug (or medical device).
* Prior exposure to lesinurad (RDEA594) or RDEA806.

**Healthy Volunteers:** True

**Maximum Age:** 55 Years

**Minimum Age:** 20 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Glendale

**Country:** United States

**State:** California

**Zip:** 91206

#### Overall Officials

**Official 1:**

**Affiliation:** Ardea Biosciences, Inc.

**Name:** S Bradley, MD

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M9177

- Name: Gout

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Ancestors

- ID: D000006074

- Term: Gout Suppressants

- ID: D000018501

- Term: Antirheumatic Agents

- ID: D000014528

- Term: Uricosuric Agents

### Intervention Browse Module - Browse Branches

- Abbrev: ARhu

- Name: Antirheumatic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M262584

- Name: Lesinurad

- Relevance: HIGH

- As Found: Recurrent small lymphocytic lymphoma

- ID: M20604

- Name: Antirheumatic Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000593471

- Term: Lesinurad

### Misc Info Module

- Version Holder: 2024-05-24
