Determinants of Warfarin Metabolism

This study is currently recruiting participants.

Verified by Hadassah Medical Organization, October 2008

Sponsored by:	Hadassah Medical Organization
Information provided by:	Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT00162474

Purpose

The anticoagulant effect of warfarin varies greatly among individuals. Some of this variability is attributed to differences in the activity of CYP2C9, the predominant enzyme involved in the metabolism of S-warfarin.

The present study is designed to define the differences in warfarin metabolism among healthy individuals carrying different CYP2C9 genotypes. In addition, the study will define the correlation between the phenytoin metabolic ratio, a marker of CYP2C9 activity in vivo, and warfarin metabolism.

Condition	Intervention
Healthy	Drug: Warfarin Drug: Phenytoin

MedlinePlus related topics: Blood Thinners

Drug Information available for: Warfarin Warfarin potassium Warfarin sodium Phenytoin Phenytoin sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Official Title:	Correlation Between Phenotypic Activity of CYP2C9 and Genetic Polymorphism in CYP2C9 and Warfarin Metabolism.

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:

Warfarin oral clearance
Formation clearance of CYP2C9 mediated warfarin metabolites

Estimated Enrollment:	200
Study Start Date:	September 2003

Eligibility

Ages Eligible for Study:	20 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Age range of 20-50 years old
The absence of significant disease states

Exclusion Criteria:

Known hypersensitivity to warfarin or phenytoin
The presence of significant disease states
Regular use of drugs (including birth control pills)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00162474

Contacts

Contact: Yoseph Caraco, MD

00 972 2 6778584

caraco@hadassah.org.il

Locations

Israel
Hadassah Medical Organization	Recruiting
Jerusalem, Israel
Contact: Arik Tzukert, DMD 00 972 2 6776095 arik@hadassah.org.il
Contact: Hadas Lemberg, PhD 00 972 2 6777572 lhadas@hadassah.org.il
Principal Investigator: Yoseph Caraco, MD

Sponsors and Collaborators

Hadassah Medical Organization

Investigators

Principal Investigator:

Yoseph Caraco, MD

Hadassah Medical Organization, Jerusalem, Israel

More Information

Study ID Numbers:	yc195510-HMO-CTIL
Study First Received:	September 11, 2005
Last Updated:	October 28, 2008
ClinicalTrials.gov Identifier:	NCT00162474
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:

Healthy Volunteers

Study placed in the following topic categories:

Phenytoin
Warfarin
Healthy

Additional relevant MeSH terms:

Anticoagulants
Therapeutic Uses
Hematologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009