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

Completed · Phase 1

Conditions studied: Healthy

In brief

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

Key facts

Study ID

NCT00651638

Run by

ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)

People needed

17

Starts

2008-03-01

Expected to finish

2008-06-01

Last updated by the study team

2008-06-19

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Covance Clinical Research Unit, Inc. — Evansville, Indiana, United States

Full record on ClinicalTrials.gov

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