A Study of ARQ 197 in Healthy Volunteers to Assess the Ph... | NCT00651638

Status Module

Record Verification Date

Jun 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

May 2008Actual

Completion Date

Jun 2008Actual

First Submitted Date

Mar 27, 2008

First Submission Date that Met QC Criteria

Apr 1, 2008

First Posted Date

Apr 3, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 18, 2008

Last Update Posted Date

Jun 19, 2008Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

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

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

17Actual

Name	Type	Description	Arm Group Labels	Other Names
Treatment with ARQ 197	Drug	Treatment with ARQ 197

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To assess the PK and safety profiles of ARQ 197 in extensive and poor metabolizers, as defined by CYP 2C19 genotype		May 2008

Secondary Outcomes

Measure	Description	Time Frame
To assess the effect of other CYP genotypes on the safety profile and PK profile of ARQ 197		May 2008

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ronald Kimberlin, MD	Covance Clinical Research Unit	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Covance Clinical Research Unit, Inc.		Evansville	Indiana	47714	United States

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

MeSH Terms

ID	Term
D013812	Therapeutics
C551661	ARQ 197