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Completed

NCT Number: NCT00651638

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

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

Completed

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit, Inc.

Evansville, Indiana, 47714, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treatment with ARQ 197

Drug

Treatment with ARQ 197

Primary outcomes

  1. 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

  1. To assess the effect of other CYP genotypes on the safety profile and PK profile of ARQ 197

    Time frame: May 2008

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Apr 3, 2008
Registry last updated
Jun 19, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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