Determinants of Warfarin Metabolism

Hadassah Medical Organization600 enrolled

Overview

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

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

600

Conditions

Healthy

Interventions

WarfarinDRUG

PhenytoinDRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Hadassah Medical Organization

Jerusalem, Israel

RECRUITING

Outcomes

Primary Outcomes

Warfarin oral clearance

Time frame: 2 weeks

Formation clearance of CYP2C9 mediated warfarin metabolites

Time frame: 2 weeks

Central Contacts

Yoseph Caraco, MD

CONTACT

00 972 2 6778584 caraco@hadassah.org.il

Data from ClinicalTrials.gov

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