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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
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00162474
First received: September 11, 2005
Last updated: October 28, 2008
Last verified: October 2008
History of Changes
  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

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:

MedlinePlus related topics: Blood Thinners
U.S. FDA Resources

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
  More Information

No publications provided

ClinicalTrials.gov 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:
Phenytoin
Warfarin
Anticonvulsants
Central Nervous System Agents
 Therapeutic Uses
Pharmacologic Actions
Anticoagulants
Hematologic Agents

ClinicalTrials.gov processed this record on June 17, 2013