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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01359579

Enrollment

Registered

2011-05-25

Start date

2011-06-30

Completion date

2012-06-30

Last updated

2012-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Impairment

Keywords

renal impairment, phase 1, healthy volunteers

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.

Interventions

DRUGvarespladib methyl

Single oral 500 mg dose

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026