Expired Study
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Evansville, Indiana 47714


Purpose:

This is a bioequivalence study designed to compare three solid states of ARQ 197 in normal healthy volunteers using a randomized crossover design.


Study summary:

This is a bioequivalence study designed to compare three solid states of ARQ 197 in normal healthy volunteers using a randomized crossover design. The primary objective is to obtain pharmacokinetic data to assess bioequivalence among three solid states of ARQ 197: amorphous, crystalline polymorph A and crystalline polymorph B.


Criteria:

Inclusion Criteria: - Subject must provide written informed consent prior to any study related procedures - Subjects must be between the ages of 18 and 65 years - Male participants must have been surgically sterilized - Female participants must have been surgically sterilized or be post menopausal and must have a negative serum pregnancy test - All participants will be phenotypically extensive metabolizers based on their CYP C19 genotype. Exclusion Criteria: - Males who are not surgically sterilized - Females of child-bearing potential who are not surgically sterilized - Any clinically significant acute or unstable physical or psychological disease based on medical history or screening physical examination - Any clinically significant abnormality in the screening laboratory tests or ECG - Received any investigational drugs within four weeks - Human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection


NCT ID:

NCT00658554


Primary Contact:

Principal Investigator
Ronald M Kimberlin, MD
Covance Clinical Research Unit


Backup Contact:

N/A


Location Contact:

Evansville, Indiana 47714
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 20, 2018

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