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

April 11, 2008
June 18, 2008
April 2008
May 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00658554 on ClinicalTrials.gov Archive Site
To monitor safety of the three solid states of ARQ 197. [ Time Frame: May 2008 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Bioequivalence Study of ARQ 197 Amorphous and Crystalline Polymorphs A and B in Normal Healthy Volunteers
Bioequivalence Study of ARQ 197 Amorphous and Crystalline Polymorphs A and B in Normal Healthy Volunteers

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

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Healthy
Drug: ARQ 197
Treatment with ARQ 197
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
June 2008
May 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00658554
ARQ 197-113
No
Nigel Rulewski, MD Chief Medical Officer, ArQule
ArQule
Not Provided
Principal Investigator: Ronald M Kimberlin, MD Covance Clinical Research Unit
ArQule
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP