A Study of ARQ 197 in Healthy Volunteers to Assess the Pharmacokinetic (PK) Profile in Extensive and Poor Metabolizers as Defined by Cytochrome P450 2C19 (CYP 2C19) Genotype

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

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2008-06-30

Brief Summary

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To assess the PK and safety profiles of ARQ 197 in extensive and poor metabolizers, as defined by CYP 2C19 genotype

Detailed Description

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This is a pharmacokinetic study designed to compare the metabolism of ARQ 197 in normal healthy volunteers who are extensive metabolizers (EM) or poor metabolizers (PM) as defined by CYP 2C19 genotype. This is an open-label, single-dose, parallel group design in which healthy volunteer subjects will receive a single dose of ARQ 197

Conditions

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Healthy

Keywords

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PK and safety profile of ARQ 197

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Interventions

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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 old
* Male participants must be surgically sterilized
* Female participants must be surgically sterilized or post menopausal and must have a negative serum pregnancy test. Post Menopausal is defined as at least one year without menses.
* Subject must, in the opinion of the Investigator, be willing and able to complete the study procedures

Exclusion Criteria

* Subject must provide written informed consent prior to any study related procedures
* Subjects must be between the ages of 18 and 65 years old
* Male participants must be surgically sterilized
* Female participants must be surgically sterilized or post menopausal and must have a negative serum pregnancy test. Post Menopausal is defined as at least one year without menses.
* Subject must, in the opinion of the Investigator, be willing and able to complete the study procedures

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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ArQule, Inc.

Principal Investigators

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Ronald 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 197-112

Identifier Type: -

Identifier Source: org_study_id