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
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: 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 July 20, 2014