## Protocol Section
### Identification Module
**NCT ID:** NCT01359579

**Brief Title:** A Study of the Pharmacokinetics and Safety of Varespladib in Subjects With Normal or Impaired Renal Function

**Official Title:** A Phase 1, Open-label, Pharmacokinetic, Safety, and Tolerability Study of a Single Oral Dose of Varespladib Methyl in Subjects With Normal Renal Function, and Subjects With Mild, Moderate, or Severe Renal Impairment

#### Organization Study ID Info
**ID:** AN-CVD2213
#### Organization
**Class:** INDUSTRY
**Full Name:** Anthera Pharmaceuticals
### Status Module
#### Completion Date
**Date:** 2012-06

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2012-03-20

**Type:** ESTIMATED

**Last Update Submit Date:** 2012-03-19

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2012-04

**Type:** ESTIMATED

#### Start Date
**Date:** 2011-06

**Status Verified Date:** 2012-03

#### Study First Post Date
**Date:** 2011-05-25
**Type:** ESTIMATED
**Study First Submit Date:** 2011-05-19
**Study First Submit QC Date:** 2011-05-23
**Why Stopped:** Lack of efficacy
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Anthera Pharmaceuticals

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is to compare and evaluate the pharmacokinetic characteristics and the safety of varespladib methyl in mild or moderate renal impairment patients and healthy volunteers.

### Conditions Module

**Conditions:**

- Renal Impairment

**Keywords:**

- renal impairment

- phase 1

- healthy volunteers

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 28

**Type:** ACTUAL

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: varespladib methyl

**Label:** Subjects with mild renal impairment

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Drug: varespladib methyl

**Label:** Subjects with moderate renal impairment

**Type:** EXPERIMENTAL

#### Arm Group 3

**Intervention Names:**

- Drug: varespladib methyl

**Label:** Subjects with normal renal function

**Type:** EXPERIMENTAL

#### Arm Group 4

**Intervention Names:**

- Drug: varespladib methyl

**Label:** Subjects with severe renal impairment

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Subjects with mild renal impairment

- Subjects with moderate renal impairment

- Subjects with normal renal function

- Subjects with severe renal impairment

**Description:** Single oral 500 mg dose

**Name:** varespladib methyl

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Measure of blood and urine levels of varespladib in subjects with renal impairment in comparison to subjects with normal renal function

**Time Frame:** PK samples will be collected predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48, and 72 hours postdose

#### Secondary Outcomes

**Measure:** Safety measures to include adverse events and changes in clinical laboratory results

**Time Frame:** From admistration of study drug through follow-up on Day 8

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Males and non-pregnant, non-lactating females 18 years or older with a BMI of 18-40 kg/m2 inclusive.
* Regarding renal function, subjects will be classified as either normal or as suffering from mild,moderate or severe renal impairment. Classification of renal impairment will be estimated by the MDRD and Cockcroft-Gault formulae

Exclusion Criteria:

* Any disease, condition and/or chronic medications which might compromise the hematologic, cardiovascular, pulmonary renal, gastrointestinal, hepatic, or central nervous system; or other conditions that might interfere with the distribution, metabolism or excretion of study drug, or would place the subject at increased risk
* Evidence of significant respiratory, gastrointestinal or hepatic disease at screening
* Positive screen for hepatitis B surface antigen, or HIV
* Positive test in drugs of abuse screens or alcohol on admission to the clinic

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Orlando

**Country:** United States

**Facility:** Investigator Site 101

**State:** Florida

**Zip:** 32809

**Location 2:**

**City:** Minneapolis

**Country:** United States

**Facility:** Investigator Site 102

**State:** Minnesota

**Zip:** 55404

**Location 3:**

**City:** Knoxville

**Country:** United States

**Facility:** Investigator Site 103

**State:** Tennessee

**Zip:** 37920

## 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: M26718

- Name: Renal Insufficiency

- Relevance: HIGH

- As Found: Renal Impairment

- ID: M10698

- Name: Kidney Diseases

- Relevance: LOW

- As Found: Unknown

- 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: D000064801

- Term: Phospholipase A2 Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M346839

- Name: Varespladib methyl

- Relevance: HIGH

- As Found: DC1

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000545088

- Term: Varespladib methyl

### Misc Info Module

- Version Holder: 2024-05-24
