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

NCT00658554 | Completed Phase 1

• 1 other identifier: ARQ 197-113
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To monitor safety of the three solid states of ARQ 197.

  May 2008

Interventions

ARQ 197 DRUG

Treatment with ARQ 197

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA): lead

Study Sites (1)

Covance Clinical Research Unit, Inc.

Evansville, Indiana, 47714, United States

Location

MeSH Terms

Interventions

ARQ 197

Study Officials

• Ronald M Kimberlin, MD

  Covance Clinical Research Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Expanded Access: Yes

Study Record Dates

• First Submitted: April 11, 2008
• First Posted: April 15, 2008
• Study Start: April 1, 2008
• Primary Completion: May 1, 2008
• Study Completion: June 1, 2008
• Last Updated: June 19, 2008

Record last verified: 2008-06

Locations

US (1)