MedTrace Logo

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

NCT00658554 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2008-06-19

No results posted yet for this study

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

Interventions

DRUG

ARQ 197

Treatment with ARQ 197

Sponsors & Collaborators

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

    lead INDUSTRY

Principal Investigators

  • Ronald M Kimberlin, MD · Covance Clinical Research Unit

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2008-05-31
Completion
2008-06-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00658554 on ClinicalTrials.gov