Bioequivalence Study of ARQ 197 Amorphous and Crystalline... | NCT00658554

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

NCT00658554

Sponsor

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

Status

Completed

Last Update Posted

Jun 19, 2008Estimated

Enrollment

24Actual

Phase

Phase 1

Conditions

Healthy

Interventions

ARQ 197

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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

Yes

Start Date

Apr 2008

Primary Completion Date

May 2008Actual

Completion Date

Jun 2008Actual

First Submitted Date

Apr 11, 2008

First Submission Date that Met QC Criteria

Apr 14, 2008

First Posted Date

Apr 15, 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

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

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.

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

24Actual

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To obtain pharmacokinetic data to assess bioequivalence among three solid states of ARQ 197: amorphous, crystalline polymorph A and crystalline polymorph B.		May 2008

Secondary Outcomes

Measure	Description	Time Frame
To monitor safety of the three solid states 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
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

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 M 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