Determinants of Warfarin Metabolism

Hadassah Medical Center

Status: Enrolling

Conditions: Healthy

Treatments: Drug: Dicloxacillin; Drug: Flurbiprofen; Drug: Losartan & Hydrochlorothiazide; Drug: Siponimod; Drug: Phenytoin; Drug: Warfarin

Study type: Interventional

Funder types: Other

Identifiers

NCT00162474

yc195510-HMO-CTIL

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age range of 20-50 years old
• The absence of significant disease states

Exclusion criteria

• Known hypersensitivity to warfarin or phenytoin
• Known hepersensitivity to penicillins or cephalosporins (Dicloxacillin part)
• The presence of significant disease states
• Regular use of drugs (including birth control pills)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,000 participants in 1 patient group

CYP2C9 substrate: Warfarin, Phenytoin, Losartan, Flurbiprofen, Siponimod.

Experimental group

Description:

Each participant may be given at least one of the following CYP2C9 substrates: Warfarin, Phenytoin, Losartan, Flurbiprofen and Siponimod.

Treatment:

Drug: Warfarin

Drug: Phenytoin

Drug: Siponimod

Drug: Losartan & Hydrochlorothiazide

Drug: Flurbiprofen

Drug: Dicloxacillin