Status:
COMPLETED
Bioequivalence Study of ARQ 197 Amorphous and Crystalline Polymorphs A and B in Normal Healthy Volunteers
Lead Sponsor:
ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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.
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 d...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00658554
Start Date
April 1 2008
End Date
June 1 2008
Last Update
June 19 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Covance Clinical Research Unit, Inc.
Evansville, Indiana, United States, 47714