Status:
COMPLETED
Pharmacogenetics of Warfarin Induction and Inhibition
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
National Institute of General Medical Sciences (NIGMS)
Conditions:
Healthy
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
This research study will help determine how a person's genetic makeup affects their response to drugs, the ability of the body to break down drugs, and their potential to experience an interaction bet...
Detailed Description
The research question is: How does CYP2C9 genotype modify warfarin drug interactions? People differ in their genetic makeup. This includes differences in genes involved in drug metabolism, transport,...
Eligibility Criteria
Inclusion
- Subjects will be 18-60 years old.
- Women of child bearing age must be willing to use measures to avoid conception during the study period.
- Subjects must agree not to take any known substrates, inhibitors, inducers or activators of either CYP2C9 or CYP3A4 from 1 week prior to the start of each study through the last day of study.
Exclusion
- Current cigarette smoker
- Abnormal renal, liver function tests, physical exam, or recent history of hepatic, renal, gastrointestinal or neoplastic disease.
- Allergy to warfarin, fluconazole or rifampin and other chemically related drugs.
- Recent ingestion (\< 1 week) of any medication known to be metabolized by or alter CYP2C9 or CYP3A4 activity.
- A positive pregnancy test at the time of the pharmacokinetic study.
- Lab tests indicative of abnormal blood clotting capacity.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT01447511
Start Date
May 1 2009
End Date
June 1 2013
Last Update
November 14 2018
Active Locations (1)
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1
Clinical and Translational Science Institute
Minneapolis, Minnesota, United States, 55414