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

NCT01359579 | Terminated Phase 1

• 1 other identifier: AN-CVD2213
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 3

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

Renal Impairment

Keywords

renal impairment; phase 1; healthy volunteers

Outcome Measures

Primary Outcomes (1)

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

  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 (1)

• Safety measures to include adverse events and changes in clinical laboratory results

  From admistration of study drug through follow-up on Day 8

Study Arms (4)

Subjects with mild renal impairment

EXPERIMENTAL

Drug: varespladib methyl

Subjects with moderate renal impairment

EXPERIMENTAL

Drug: varespladib methyl

Subjects with normal renal function

EXPERIMENTAL

Drug: varespladib methyl

Subjects with severe renal impairment

EXPERIMENTAL

Drug: varespladib methyl

Interventions

varespladib methyl DRUG

Single oral 500 mg dose

Subjects with mild renal impairment; Subjects with moderate renal impairment; Subjects with normal renal function; Subjects with severe renal impairment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Anthera Pharmaceuticals: lead

Study Sites (3)

Investigator Site 101

Orlando, Florida, 32809, United States

Location

Investigator Site 102

Minneapolis, Minnesota, 55404, United States

Location

Investigator Site 103

Knoxville, Tennessee, 37920, United States

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

varespladib methyl

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2011
• First Posted: May 25, 2011
• Study Start: June 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: June 1, 2012
• Last Updated: March 20, 2012

Record last verified: 2012-03

Locations

US (3)