A Study of the Pharmacokinetics and Safety of Varespladib in Subjects With Normal or Impaired Renal Function
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ClinicalTrials.gov Identifier: NCT01359579
Recruitment Status :
(Lack of efficacy)
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
Study Start Date :
Estimated Primary Completion Date :
Estimated Study Completion Date :
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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 ]
Secondary Outcome Measures :
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 ]
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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