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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of INCB054707 in Participants With Normal and Impaired Renal Function and Participants on Hemodialysis

NCT05624723

Renal Insufficiency Kidney Diseases

COMPLETED PHASE1

A Multi-Center, Open-Label Study

NCT01468259

Renal Disease End Stage Renal Disease

WITHDRAWN PHASE1

A Study to Evaluate Pharmacokinetics (PK) and Safety of Inaxaplin in Participants With Renal Impairment

NCT05865171

Renal Impairment

COMPLETED PHASE1

A Study to Evaluate Pharmacokinetic and Safety Trial of Emraclidine in Participants With Renal Impairment Compared With Participants With Normal Renal Function

NCT05940402

Renal Impairment

COMPLETED PHASE1

PK Study in Subjects With Renal Impairment (Severe and if Required Mild & Moderate) Compared to Subjects With Normal Renal Function

NCT04656795

Renal Impairment Normal Renal Function

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Renal Impairment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Subjects with mild renal impairment

Group Type EXPERIMENTAL

varespladib methyl

Intervention Type DRUG

Single oral 500 mg dose

Subjects with moderate renal impairment

Group Type EXPERIMENTAL

varespladib methyl

Intervention Type DRUG

Single oral 500 mg dose

Subjects with normal renal function

Group Type EXPERIMENTAL

varespladib methyl

Intervention Type DRUG

Single oral 500 mg dose

Subjects with severe renal impairment

Group Type EXPERIMENTAL

varespladib methyl

Intervention Type DRUG

Single oral 500 mg dose

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

varespladib methyl

Single oral 500 mg dose

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes