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)

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Treatment with ARQ 197

Study type

Interventional

Funder types

Industry

Identifiers

NCT00651638

ARQ 197-112

Details and patient eligibility

About

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

Full 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

Enrollment

17 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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