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

March 19, 2012 updated by: Anthera Pharmaceuticals

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32809
        • Investigator site 101
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Investigator site 102
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Investigator site 103

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Subjects with mild renal impairment
Drug: varespladib methyl
Single oral 500 mg dose
Experimental: Subjects with moderate renal impairment
Drug: varespladib methyl
Single oral 500 mg dose
Experimental: Subjects with normal renal function
Drug: varespladib methyl
Single oral 500 mg dose
Experimental: Subjects with severe renal impairment
Drug: varespladib methyl
Single oral 500 mg dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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

Outcome Measure
Time Frame
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
From admistration of study drug through follow-up on Day 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anthera Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Anticipated)

April 1, 2012

Study Completion (Anticipated)

June 1, 2012

Study Registration Dates

First Submitted

May 19, 2011

First Submitted That Met QC Criteria

May 23, 2011

First Posted (Estimate)

May 25, 2011

Study Record Updates

Last Update Posted (Estimate)

March 20, 2012

Last Update Submitted That Met QC Criteria

March 19, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AN-CVD2213

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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