Genetic Variability in the Response to Warfarin at Baseline and During Induction of CYP2C9

Hadassah Medical Organization150 enrolled

Overview

The genetic factors associated with variability in CYP2C9 induction have not been elucidated. The hypothesis underlying this study is that following 7 days treatment with rifampicin, a known CYP450 inducer, the genetic variability in regulatory elements controlling CYP2C9 expression will be associated with the magnitude of change in INR response to warfarin and in CYP2C9-mediated warfarin metabolism.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

150

Conditions

Healthy Subjects

Interventions

RifampicinDRUG

oral, 450 mg/day , 7 days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy subjects Exclusion Criteria: * Consumption of any medication during 30 days * Smoking * Alcohol consumption

Locations (1)

Hadassah Hebrew University Medical Center

Jerusalem, Israel

Outcomes

Primary Outcomes

International Normalized Ratio (INR)

Time frame: 6 weeks

Secondary Outcomes

Warfarin concentration

Time frame: 6 weeks

Central Contacts

Mordechai Muszkat, MD

CONTACT

972-6777111 muszkatm@hadassah.org.il

Data from ClinicalTrials.gov

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