NCT00651638CompletedPhase 1
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
ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)2 sites in 1 country17 target enrollmentStarted: March 1, 2008Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 17
- Locations
- 2
- Primary Endpoint
- To assess the PK and safety profiles of ARQ 197 in extensive and poor metabolizers, as defined by CYP 2C19 genotype
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
To assess the PK and safety profiles of ARQ 197 in extensive and poor metabolizers, as defined by CYP 2C19 genotype
Time Frame: May 2008
Secondary Outcomes
- To assess the effect of other CYP genotypes on the safety profile and PK profile of ARQ 197(May 2008)
Investigators
Study Sites (2)
Loading locations...
Similar Trials
Completed
Phase 1
Study of ARQ 197 in Hepatocellular Carcinoma (HCC)Advanced Hepatocellular CarcinomaNCT01656265Kyowa Kirin Co., Ltd.24
Completed
Phase 1
Safety Study of ARQ 197 in Cirrhotic Patients With Hepatocellular Carcinoma (HCC)Hepatocellular CarcinomaCirrhosisNCT00802555ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)21
Completed
Phase 1
A Phase 1 Study of ARQ 197 in Adult Patients With Advanced Solid TumorsCancerNCT00612703ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)32
Completed
Phase 1
A Study of ARQ 197 in Combination With ErlotinibNon-small-cell Lung CancerNCT01069757Kyowa Kirin Co., Ltd.16
Completed
Phase 1
A Study of ARQ 197 in Combination With ErlotinibAdvanced/Recurrent Non-small-cell Lung CancerNCT01251796Kyowa Kirin Co., Ltd.9