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NCT01173640 · ClinicalTrials.gov registry record · NA
Resveratrol and Midazolam Metabolism
A NA study, sponsored by University of Washington.
- Completed
- Registry status
- NA
- Development phase
- 6
- Enrollment target
NCT01173640 is a NA study that has completed, run by University of Washington. The registered enrollment target is 6 participants.
The verdict
NCT01173640, a NA study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- NA
- Development phase
- 6 participants
- Enrollment target
Study Summary
Adverse events due to drug-drug and/or herb-drug interactions are of serious concern and a major cause of morbidity and mortality. Resveratrol is a polyphenol antioxidant that has been identified in over 70 species and is suggested to be the constituent in red wine responsible for cardioprotective effects. The potential health benefits of resveratrol supplements are highly extolled in the alternative medicine industry and daily doses are up to 5 grams are being studied. While there are potential health benefits of high doses of resveratrol, for patients taking other drugs metabolized by CYP3A4, such as transplant medications, chemotherapies and HMG-CoA reductase inhibitors, there may be a clinically significant herb-drug interaction. We, the investigators, have shown in vitro that resveratrol is a mechanism-based inhibitor of cytochrome P450 3A4 (CYP3A4). Based on our in vitro evidence and literature reports of the pharmacokinetics of resveratrol, we hypothesize that resveratrol will be a potent in vivo mechanism-based inhibitor of intestinal CYP3A4 enzymes. To date, there are no clinical studies that address the potential for a resveratrol-drug interaction. We propose to test whether single and multiple doses of resveratrol alter the pharmacokinetics of midazolam, a prototypic CYP3A4 probe drug.
Interventions
- DRUG Midazolam
- DIETARY_SUPPLEMENT resveratrol (single dose)
- DIETARY_SUPPLEMENT resveratrol (multiple dose)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2010-07 |
| Est. Completion | 2011-02 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01173640
The ClinicalTrials.gov registry entry for NCT01173640 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Midazolam is the first listed.
NCT01173640 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01173640 about?
NCT01173640 is a clinical study titled "Resveratrol and Midazolam Metabolism". Adverse events due to drug-drug and/or herb-drug interactions are of serious concern and a major cause of morbidity and mortality. Resveratrol is a polyphenol antioxidant that has been identified in over 70 species and is suggested to be the constituent in red wine responsible for cardioprotective e...
What is the current status of trial NCT01173640?
This trial is currently completed. It is a NA study. The enrollment target is 6 participants. The study started on 2010-07. Estimated completion is 2011-02.
What interventions are being tested in trial NCT01173640?
The interventions under investigation include: Midazolam (DRUG), resveratrol (single dose) (DIETARY_SUPPLEMENT), resveratrol (multiple dose) (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01173640?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
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