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NCT01061112 · ClinicalTrials.gov registry record
Effects of Genotype on CYP2C9 Drug Interactions
A clinical trial, sponsored by University of Minnesota.
- Completed
- Registry status
- 23
- Enrollment target
NCT01061112 is a clinical trial that has completed, run by University of Minnesota. The registered enrollment target is 23 participants.
The verdict
NCT01061112 has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- 23 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Flurbiprofen Control - Flurbiprofen Only
- DRUG Flurbiprofen Inhibition - Flurbiprofen & Fluconazole
- DRUG Ketoprofen Control - Ketoprofen Only
- DRUG Ketoprofen Inhibition - Ketoprofen & Fluconazole
- DRUG Tolbutamide Control - Tolbutamide Only
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2009-12 |
| Est. Completion | 2014-06 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01061112
The ClinicalTrials.gov registry entry for NCT01061112 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Flurbiprofen Control - Flurbiprofen Only is the first listed.
NCT01061112 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01061112 about?
NCT01061112 is a clinical study titled "Effects of Genotype on CYP2C9 Drug Interactions". 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 fluconazol...
What is the current status of trial NCT01061112?
This trial is currently completed. The enrollment target is 23 participants. The study started on 2009-12. Estimated completion is 2014-06.
What interventions are being tested in trial NCT01061112?
The interventions under investigation include: Flurbiprofen Control - Flurbiprofen Only (DRUG), Flurbiprofen Inhibition - Flurbiprofen & Fluconazole (DRUG), Ketoprofen Control - Ketoprofen Only (DRUG), Ketoprofen Inhibition - Ketoprofen & Fluconazole (DRUG), Tolbutamide Control - Tolbutamide Only (DRUG).
Who is sponsoring clinical trial NCT01061112?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
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