Bioequivalence Study of ARQ 197 Amorphous and Crystalline Polymorphs A and B in Normal Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
ArQule
ClinicalTrials.gov Identifier:
NCT00658554
First received: April 11, 2008
Last updated: June 18, 2008
Last verified: June 2008
  Purpose

This is a bioequivalence study designed to compare three solid states of ARQ 197 in normal healthy volunteers using a randomized crossover design.


Condition Intervention Phase
Healthy
Drug: ARQ 197
Phase 1

ArQule has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Bioequivalence Study of ARQ 197 Amorphous and Crystalline Polymorphs A and B in Normal Healthy Volunteers

Further study details as provided by ArQule:

Primary Outcome Measures:
  • To obtain pharmacokinetic data to assess bioequivalence among three solid states of ARQ 197: amorphous, crystalline polymorph A and crystalline polymorph B. [ Time Frame: May 2008 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To monitor safety of the three solid states of ARQ 197. [ Time Frame: May 2008 ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: April 2008
Study Completion Date: June 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: ARQ 197
    Treatment with ARQ 197
Detailed Description:

This is a bioequivalence study designed to compare three solid states of ARQ 197 in normal healthy volunteers using a randomized crossover design.

The primary objective is to obtain pharmacokinetic data to assess bioequivalence among three solid states of ARQ 197: amorphous, crystalline polymorph A and crystalline polymorph B.

  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
  • Male participants must have been surgically sterilized
  • Female participants must have been surgically sterilized or be post menopausal and must have a negative serum pregnancy test
  • All participants will be phenotypically extensive metabolizers based on their CYP C19 genotype.

Exclusion Criteria:

  • Males who are not surgically sterilized
  • Females of child-bearing potential who are not surgically sterilized
  • Any clinically significant acute or unstable physical or psychological disease based on medical history or screening physical examination
  • Any clinically significant abnormality in the screening laboratory tests or ECG
  • Received any investigational drugs within four weeks
  • Human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00658554

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

No publications provided

Responsible Party: Nigel Rulewski, MD Chief Medical Officer, ArQule
ClinicalTrials.gov Identifier: NCT00658554     History of Changes
Other Study ID Numbers: ARQ 197-113
Study First Received: April 11, 2008
Last Updated: June 18, 2008
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 17, 2014