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...
Date First Received: September 11, 2005
Last Updated: March 17, 2008
Verified by: Hadassah Medical Organization, March 2008
Clinical Trial Phase: N/A | Start Date: September 2003
Overall Status: Recruiting
Estimated Enrollment: 200
Brief Summary
Official Title: “Correlation Between Phenotypic Activity of CYP2C9 and Genetic Polymorphism in CYP2C9 and Warfarin Metabolism.”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Other, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Intervention(s) in this Clinical Trial
- Drug: Warfarin
- Drug: Phenytoin
Outcome Measures for this Clinical Trial
Primary Measures
- Warfarin oral clearance
- Formation clearance of CYP2C9 mediated warfarin metabolites
Criteria for Participation in this Clinical Trial
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)
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 20 Years
Maximum Age for this Clinical Trial: 50 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: Hadassah Medical Organization
Overall Clinical Trial Officials and Contacts
Yoseph Caraco, MD Principal Investigator Hadassah Medical Organization, Jerusalem, Israel
Overall Contact: Yoseph Caraco, MD 00 972 2 6778584 caraco@hadassah.org.il
Additional Information
Information obtained from ClinicalTrials.gov on October 10, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00162474
Study ID Number: yc195510-HMO-CTIL
ClinicalTrials.gov Identifier: NCT00162474
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration
Clinical Trials Authorship and Review
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