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Determinants of Warfarin Metabolism

H

Hadassah Medical Center

Status

Unknown

Conditions

Healthy

Treatments

Drug: Warfarin
Drug: Phenytoin

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

600 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
  • 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)

600 participants in 1 patient group

Warfarin
Experimental group
Treatment:
Drug: Warfarin
Drug: Phenytoin

Trial contacts and locations

1

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Central trial contact

Yoseph Caraco, MD

Data sourced from clinicaltrials.gov

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