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NCT01388075 Clinical Trial

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

Healthy Subjects Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01388075
Other study ID # HMO-0451-10
Secondary ID
Status Not yet recruiting
Phase N/A
First received July 3, 2011
Last updated July 5, 2011
Start date July 2011

Study information
Verified date July 2011
Source Hadassah Medical Organization
Contact Mordechai Muszkat, MD
Phone 972-6777111
Email muszkatm@hadassah.org.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 150
Est. completion date
Est. primary completion date June 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Healthy subjects

Exclusion Criteria:

- Consumption of any medication during 30 days

- Smoking

- Alcohol consumption

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Drug:
• Rifampicin
oral, 450 mg/day , 7 days

Locations
Country Name City State
Israel Hadassah Hebrew University Medical Center Jerusalem

Sponsors (1)
Lead Sponsor Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary International Normalized Ratio (INR) 6 weeks Yes
Secondary Warfarin concentration 6 weeks No
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