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A Study of the Pharmacokinetics and Safety of Varespladib in Subjects With Normal or Impaired Renal Function | Clinical Trials | Clareo Health

TERMINATEDPHASE1

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

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

NCT01359579•Anthera Pharmaceuticals

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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

Locations (3)

Investigator Site 101

Orlando, Florida, United States

Investigator Site 102

Minneapolis, Minnesota, United States

Investigator Site 103

Knoxville, Tennessee, United States

Key Dates

Start Date

June 1, 2011

Primary Completion Date

April 1, 2012

Completion Date

June 1, 2012

Last Updated

March 20, 2012

Enrollment

ACTUAL participants

Conditions

Renal Impairment

Interventions

varespladib methyl

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Investigation of the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Opemalirsen (AZD2373)

A Study of Pharmacokinetics and Safety of LY3537031 in Participants With Normal Renal Function and Participants With Renal Impairment

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DESIR. Evaluation of the Pre-therapeutic Activity of Dihydropyrimidine dEShydrogenase (DPD) in Patients With Cancer and/or Renal Failure