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
Phase 1
Completed
- Conditions
- Healthy
- Registration Number
- NCT00651638
- Lead Sponsor
- ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
- 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. This is an open-label, single-dose, parallel group design in which healthy volunteer subjects will receive a single dose of ARQ 197
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 17
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method To assess the PK and safety profiles of ARQ 197 in extensive and poor metabolizers, as defined by CYP 2C19 genotype May 2008
- Secondary Outcome Measures
Name Time Method To assess the effect of other CYP genotypes on the safety profile and PK profile of ARQ 197 May 2008
Trial Locations
- Locations (1)
Covance Clinical Research Unit, Inc.
🇺🇸Evansville, Indiana, United States