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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

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ClinicalTrials.gov Identifier: NCT00651638
Recruitment Status : Completed
First Posted : April 3, 2008
Last Update Posted : June 19, 2008
Sponsor:
Information provided by:
ArQule

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Treatment with ARQ 197 Phase 1

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
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
Study Start Date : March 2008
Actual Primary Completion Date : May 2008
Actual Study Completion Date : June 2008

Intervention Details:
  • Drug: Treatment with ARQ 197
    Treatment with ARQ 197


Primary Outcome Measures :
  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 Outcome Measures :
  1. To assess the effect of other CYP genotypes on the safety profile and PK profile of ARQ 197 [ Time Frame: May 2008 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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

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

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

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