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

Phase 1

Terminated

• Conditions: Renal Impairment
• Interventions: Drug: varespladib methyl

• Registration Number: NCT01359579
• Lead Sponsor: Anthera Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-05-19
• Study First Submitted QC: 2011-05-23
• Study First Posted: 2011-05-25
• Study Start: 2011-06
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-19
• Last Update Posted: 2012-03-20
• Primary Completion: 2012-04
• Study Completion: 2012-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 28

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Subjects with mild renal impairment	varespladib methyl	-
Subjects with moderate renal impairment	varespladib methyl	-
Subjects with severe renal impairment	varespladib methyl	-
Subjects with normal renal function	varespladib methyl	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Safety measures to include adverse events and changes in clinical laboratory results	From admistration of study drug through follow-up on Day 8

Trial Locations

Locations (3)

Investigator Site 101; 🇺🇸 Orlando, Florida, United States

Investigator Site 103; 🇺🇸 Knoxville, Tennessee, United States

Investigator Site 102; 🇺🇸 Minneapolis, Minnesota, United States