Determinants of Warfarin Metabolism

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Hadassah Medical Organization.
Recruitment status was  Recruiting
Information provided by:
Hadassah Medical Organization Identifier:
First received: September 11, 2005
Last updated: October 28, 2008
Last verified: October 2008

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
Drug: Warfarin
Drug: Phenytoin

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Correlation Between Phenotypic Activity of CYP2C9 and Genetic Polymorphism in CYP2C9 and Warfarin Metabolism.

Resource links provided by NLM:

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

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00162474

Contact: Yoseph Caraco, MD 00 972 2 6778584

Hadassah Medical Organization Recruiting
Jerusalem, Israel
Contact: Arik Tzukert, DMD    00 972 2 6776095   
Contact: Hadas Lemberg, PhD    00 972 2 6777572   
Principal Investigator: Yoseph Caraco, MD         
Sponsors and Collaborators
Hadassah Medical Organization
Principal Investigator: Yoseph Caraco, MD Hadassah Medical Organization
  More Information

No publications provided Identifier: NCT00162474     History of Changes
Other Study ID Numbers: yc195510-HMO-CTIL
Study First Received: September 11, 2005
Last Updated: October 28, 2008
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
Healthy Volunteers

Additional relevant MeSH terms:
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses processed this record on November 27, 2015