Healthy
Conditions
Keywords
PK and safety profile of ARQ 197
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
Interventions
DRUGTreatment with ARQ 197
Treatment with ARQ 197
Sponsors
ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the PK and safety profiles of ARQ 197 in extensive and poor metabolizers, as defined by CYP 2C19 genotype | May 2008 |
Secondary
| Measure | Time frame |
|---|---|
| To assess the effect of other CYP genotypes on the safety profile and PK profile of ARQ 197 | May 2008 |
Countries
United States
Outcome results
None listed