Status:
COMPLETED
A Study of ARQ 197 in Healthy Volunteers to Assess the Pharmacokinetic (PK) Profile in Extensive and Poor Metabolizers as Defined by Cytochrome P450 2C19 (CYP 2C19) Genotype
Lead Sponsor:
ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
To assess the PK and safety profiles of ARQ 197 in extensive and poor metabolizers, as defined by CYP 2C19 genotype
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00651638
Start Date
March 1 2008
End Date
June 1 2008
Last Update
June 19 2008
Active Locations (1)
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1
Covance Clinical Research Unit, Inc.
Evansville, Indiana, United States, 47714