At a glance
ClinicalIndex Comparison Record- ✓Age 18-60 years
- ✓Willing to avoid conception during study (women of childbearing age)
- ✓Agree to avoid CYP2C9 and CYP3A4 substrates, inhibitors, inducers, or activators from 1 week prior through study end
- ✕Current cigarette smoker
- ✕Abnormal renal or liver function tests, abnormal physical exam, or recent history of hepatic, renal, gastrointestinal, or neoplastic disease
- ✕Allergy to warfarin, fluconazole, rifampin, or chemically related drugs
- ✕Recent ingestion (<1 week) of medications metabolized by or altering CYP2C9 or CYP3A4 activity
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pharmacogenetics of Warfarin Induction and Inhibition
In Brief
A clinical study evaluating Control - Warfarin only, Fluconazole - Warfarin, and 1 other intervention for Healthy. Completed, enrolled 39 participants across 1 site.
Detailed 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 between drugs. The investigators are investigating the drug interactions with the commonly used anticoagulant drug called warfarin. Warfarin is used for the treatment and prevention of life-threatening abnormal blood clots such as deep vein thrombosis, heart attacks, and strokes. The investigators chose warfarin for this study because it is a commonly used drug and must be monitored closely to avoid side effects. The investigators are interested in studying whether individuals with certain genetic profiles react differently to warfarin when it is combined with other drugs. This research is being done to see if certain genetic profiles require us to adjust warfarin doses differently than is needed for the general population. Genetic profiles of subjects are determined from their participation in the Pharmacogenetics Registry study (investigator Richard Brundage, University of Minnesota). The study hypothesis is: Functionally defective CYP2C9 alleles attenuate the warfarin-fluconazole inhibitory interaction and exacerbate the warfarin-rifampin inductive interaction.
Study Details
Timeline
Interventions
A single 10 mg warfarin dose taken at the start of the study period. No other medications taken during this study period.
A single 10 mg warfarin dose taken at the start of the study period. 400 mg fluconazole taken every morning starting a week before the start of the study period and continuing throughout the study period.
A single 10 mg warfarin dose taken at the start of the study period. 300 mg rifampin taken every morning starting a week before the start of the study period and continuing throughout the study period.