Determinants of Warfarin Metabolism

Not Applicable

• Conditions: Healthy
• Interventions: Drug: Warfarin; Drug: Phenytoin

• Registration Number: NCT00162474
• Lead Sponsor: Hadassah Medical Organization

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09
• Study First Submitted: 2005-09-11
• Study First Submitted QC: 2005-09-11
• Study First Posted: 2005-09-13
• Status Verified: 2018-03
• Last Update Submitted: 2018-06-11
• Last Update Posted: 2018-06-12
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Warfarin	Phenytoin	-
Warfarin	Warfarin	-

Primary Outcome Measures

Name	Time	Method
Formation clearance of CYP2C9 mediated warfarin metabolites	2 weeks
Warfarin oral clearance	2 weeks

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel