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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Evansville, Indiana, United States, 47714
      • Covance Clinical Research Unit, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To obtain pharmacokinetic data to assess bioequivalence among three solid states of ARQ 197: amorphous, crystalline polymorph A and crystalline polymorph B.	May 2008

Secondary Outcome Measures

Outcome Measure	Time Frame
To monitor safety of the three solid states of ARQ 197.	May 2008

Collaborators and Investigators

• Sponsor: ArQule, Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)
• Investigators: Principal Investigator: Ronald M Kimberlin, MD, Covance Clinical Research Unit

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): May 1, 2008
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: April 11, 2008
• First Submitted That Met QC Criteria: April 14, 2008
• First Posted (Estimate): April 15, 2008

Study Record Updates

• Last Update Posted (Estimate): June 19, 2008
• Last Update Submitted That Met QC Criteria: June 18, 2008
• Last Verified: June 1, 2008

More Information

Terms related to this study

• Other Study ID Numbers: ARQ 197-113