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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2008-06-30

Brief Summary

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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

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Interventions

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ARQ 197

Treatment with ARQ 197

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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ArQule

Principal Investigators

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Ronald M Kimberlin, MD

Role: PRINCIPAL_INVESTIGATOR

Covance Clinical Research Unit

Locations

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Covance Clinical Research Unit, Inc.

Evansville, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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ARQ 197-113

Identifier Type: -

Identifier Source: org_study_id