Status:
COMPLETED
Resveratrol and Midazolam Metabolism
Lead Sponsor:
University of Washington
Collaborating Sponsors:
Bastyr University
Conditions:
Healthy
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief 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 o...
Eligibility Criteria
Inclusion
- 18 to 50 years old.
- Body mass index between 18 and 30 kg/m2.
- Good health without a self-reported history of liver, kidney, gastrointestinal or heart disease
- Women use measures to avoid conception during the study period (e.g. oral contraceptives, intrauterine devices \[IUDs\], and condoms)
- Subjects must agree not to take any known substrates, inhibitors, inducers or activators of CYP3A4 at least 2 weeks before study start and for the entire duration of the study.
- Avoid ingesting grapefruit, grapefruit juice or other grapefruit juice containing products, and any herbal-based nutrient supplement or prescribed medications during the same period of time.
- Willing to fast overnight before the study days.
- Willing to abstain from alcohol-containing beverages 24 hours before and during the study visits, and willing to abstain from grapefruit, cranberry, blueberry products, peanuts and peanut butter, grape and grape products, and red wine at least one week prior to and during the study.
Exclusion
- Current cigarette smoker
- Self-reported history of liver, kidney, gastrointestinal or heart disease
- Abnormal liver or kidney function tests based on the Comprehensive and Hepatic Panel (below the lower end or greater than 15% of the upper end of the reference range).
- Known or suspected history of alcohol or drug abuse
- Allergic to benzodiazepines or any other chemically related drugs
- Women who are pregnant or breastfeeding
- Recent ingestion (\<1 week) of any medication known to be metabolized by CYP3A4 or alter CYP3A activity
- Chronic use of prescription drugs, over-the-counter, vitamins or natural products. However, oral contraceptives will be permitted.
- Unable to give informed consent
- Participated in another clinical trial or study within 30 days
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01173640
Start Date
July 1 2010
End Date
February 1 2011
Last Update
October 31 2017
Active Locations (1)
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1
University of Washington
Seattle, Washington, United States, 98195