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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:
ClinicalTrials.gov Identifier:
NCT00651638
First Posted: April 3, 2008
Last Update Posted: June 19, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
ArQule
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: ArQule, Inc.
ClinicalTrials.gov Identifier: NCT00651638     History of Changes
Other Study ID Numbers: ARQ 197-112
First Submitted: March 27, 2008
First Posted: April 3, 2008
Last Update Posted: June 19, 2008
Last Verified: June 2008

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