- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00651638
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
June 18, 2008 updated by: ArQule, Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)
To assess the PK and safety profiles of ARQ 197 in extensive and poor metabolizers, as defined by CYP 2C19 genotype
Study Overview
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
Study Type
Interventional
Enrollment (Actual)
17
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Indiana
-
Evansville, Indiana, United States, 47714
- Covance Clinical Research Unit, Inc.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess the PK and safety profiles of ARQ 197 in extensive and poor metabolizers, as defined by CYP 2C19 genotype
Time Frame: May 2008
|
May 2008
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess the effect of other CYP genotypes on the safety profile and PK profile of ARQ 197
Time Frame: May 2008
|
May 2008
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ronald Kimberlin, MD, Covance Clinical Research Unit
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2008
Primary Completion (Actual)
May 1, 2008
Study Completion (Actual)
June 1, 2008
Study Registration Dates
First Submitted
March 27, 2008
First Submitted That Met QC Criteria
April 1, 2008
First Posted (Estimate)
April 3, 2008
Study Record Updates
Last Update Posted (Estimate)
June 19, 2008
Last Update Submitted That Met QC Criteria
June 18, 2008
Last Verified
June 1, 2008
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ARQ 197-112
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
-
King's College LondonUniversity of ReadingCompletedHealthy | Healthy AgingUnited Kingdom
Clinical Trials on Treatment with ARQ 197
-
National Cancer Institute (NCI)TerminatedEpithelioid Mesothelioma | Sarcomatoid Mesothelioma | Stage IV Pleural Mesothelioma | Recurrent Malignant Mesothelioma | Stage II Pleural Mesothelioma | Stage III Pleural MesotheliomaUnited States
-
National Cancer Institute (NCI)CompletedChildhood Solid NeoplasmUnited States, Canada
-
National Cancer Institute (NCI)CompletedStage IV Breast Cancer | Recurrent Breast Carcinoma | Estrogen Receptor Negative | HER2/Neu Negative | Progesterone Receptor Negative | Triple-Negative Breast CarcinomaUnited States
-
Daiichi Sankyo, Inc.ICON Clinical Research; ArQule, Inc. (a wholly owned subsidiary of Merck Sharp...Completed
-
ArQule, Inc. (a wholly owned subsidiary of Merck...CompletedRenal Cell Carcinoma (RCC) | Alveolar Soft Part Sarcoma (ASPS) | Clear Cell Sarcoma (CCS)United States, Canada, United Kingdom
-
ArQule, Inc. (a wholly owned subsidiary of Merck...Completed
-
National Cancer Institute (NCI)CompletedProstate Adenocarcinoma | Recurrent Prostate Carcinoma | Stage IV Prostate Cancer | Hormone-Resistant Prostate CancerUnited States
-
Kyowa Kirin Co., Ltd.Completed
-
ArQule, Inc. (a wholly owned subsidiary of Merck...CompletedCancer, Advanced Solid TumorsUnited Kingdom
-
ArQule, Inc. (a wholly owned subsidiary of Merck...CompletedHepatocellular Carcinoma | CirrhosisSpain, United States, Italy