Expired Study
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Evansville, Indiana 47714


Purpose:

To assess the PK and safety profiles of ARQ 197 in extensive and poor metabolizers, as defined by CYP 2C19 genotype


Study summary:

This is a pharmacokinetic study designed to compare the metabolism of ARQ 197 in normal healthy volunteers who are extensive metabolizers (EM) or poor metabolizers (PM) as defined by CYP 2C19 genotype. This is an open-label, single-dose, parallel group design in which healthy volunteer subjects will receive a single dose of ARQ 197


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 old - Male participants must be surgically sterilized - Female participants must be surgically sterilized or post menopausal and must have a negative serum pregnancy test. Post Menopausal is defined as at least one year without menses. - Subject must, in the opinion of the Investigator, be willing and able to complete the study procedures Exclusion Criteria: - Subject must provide written informed consent prior to any study related procedures - Subjects must be between the ages of 18 and 65 years old - Male participants must be surgically sterilized - Female participants must be surgically sterilized or post menopausal and must have a negative serum pregnancy test. Post Menopausal is defined as at least one year without menses. - Subject must, in the opinion of the Investigator, be willing and able to complete the study procedures


NCT ID:

NCT00651638


Primary Contact:

Principal Investigator
Ronald 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: February 04, 2019

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