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

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ClinicalTrials.gov Identifier: NCT00658554
Recruitment Status : Completed
First Posted : April 15, 2008
Last Update Posted : June 19, 2008
Sponsor:
Information provided by:
ArQule

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

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

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

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Bioequivalence Study of ARQ 197 Amorphous and Crystalline Polymorphs A and B in Normal Healthy Volunteers
Study Start Date : April 2008
Actual Primary Completion Date : May 2008
Actual Study Completion Date : June 2008

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


Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To monitor safety of the three solid states 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
  • 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

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): 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

Responsible Party: Nigel Rulewski, MD Chief Medical Officer, ArQule
ClinicalTrials.gov Identifier: NCT00658554     History of Changes
Other Study ID Numbers: ARQ 197-113
First Posted: April 15, 2008    Key Record Dates
Last Update Posted: June 19, 2008
Last Verified: June 2008