Effects of Genotype on CYP2C9 Drug Interactions

Completed

Conditions studied: Healthy

In brief

This research study will help determine how a person's genetic makeup affects their responses to drugs, the ability of the body to break down drugs, and their potential to experience an interaction between drugs. We are investigating the drug interactions between an antifungal drug called fluconazole and the commonly used drugs tolbutamide, flurbiprofen, and ketoprofen. Tolbutamide is used for management of Type 2 diabetes. Both flurbiprofen and ketoprofen are non-steroidal anti-inflammatory drugs (NSAIDs) often used for arthritis or pain. We are interested in studying whether individuals with certain genetic profiles have different drug interactions than normal. This research is being done to see if certain genetic profiles require us to adjust medication doses differently than is needed for the general population. Genetic profiles of subjects are determined from their previous participation in the Pharmacogenetics Registry (Investigator Richard Brundage, University of Minnesota). The study hypothesis is: Fraction metabolized by CYP2C9 enzyme determines the extent of drug interactions in CYP2C9\*1/\*1 individuals but this factor (fraction metabolized) becomes less influential and drug interactions are attenuated in a gene-dose dependent manner in individuals with one or more defective alleles.

Key facts

Study ID

NCT01061112

Run by

University of Minnesota

People needed

23

Starts

2009-12-01

Expected to finish

2014-06-01

Last updated by the study team

2019-07-18

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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 CYP2C9.

You may not qualify if…

• Current cigarette smoker.
• Abnormal renal or liver function tests, physical exam, or recent history of hepatic, renal, gastrointestinal or neoplastic disease.
• Allergy to tolbutamide, flurbiprofen, ketoprofen, fluconazole or phenytoin and other chemically related drugs.
• Recent ingestion (< 1 week) of any medication known to be metabolized by or alter activity of CYP2C9.
• A positive pregnancy test during the time of the pharmacokinetic study.

Where it is running

• Clinical and Translational Science Institute — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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