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

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

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: ARQ 197

Study type

Interventional

Funder types

Industry

Identifiers

NCT00658554

ARQ 197-113

Details and patient eligibility

About

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

Full 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.

Enrollment

24 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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