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

Hadassah Medical Center

Status: Unknown

Conditions: Healthy Subjects

Treatments: Drug: Rifampicin

Study type: Interventional

Funder types: Other

Identifiers

NCT01388075

HMO-0451-10

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy subjects

Exclusion criteria

• Consumption of any medication during 30 days
• Smoking
• Alcohol consumption

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Double Blind

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150 participants in 1 patient group

Rifampicin

Experimental group

Description:

Consecutive treatments with rifampicin and placebo

Treatment:

Drug: Rifampicin