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

This study has been completed.
Sponsor:
Information provided by:
ArQule
ClinicalTrials.gov Identifier:
NCT00651638
First received: March 27, 2008
Last updated: June 18, 2008
Last verified: June 2008
  Purpose

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


Condition Intervention Phase
Healthy
Drug: Treatment with ARQ 197
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: 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

Further study details as provided by ArQule:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the effect of other CYP genotypes on the safety profile and PK profile of ARQ 197 [ Time Frame: May 2008 ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: March 2008
Study Completion Date: June 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Treatment with ARQ 197
    Treatment with ARQ 197
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00651638

Locations
United States, Indiana
Covance Clinical Research Unit, Inc.
Evansville, Indiana, United States, 47714
Sponsors and Collaborators
ArQule
Investigators
Principal Investigator: Ronald Kimberlin, MD Covance Clinical Research Unit
  More Information

No publications provided

Responsible Party: ArQule, Inc.
ClinicalTrials.gov Identifier: NCT00651638     History of Changes
Other Study ID Numbers: ARQ 197-112
Study First Received: March 27, 2008
Last Updated: June 18, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by ArQule:
PK and safety profile of ARQ 197

ClinicalTrials.gov processed this record on October 19, 2014