Clinical Study of Resveratrol on Drug and Carcinogen Metabolizing Enzymes
I. To determine the effect of resveratrol on human cytochrome P450 (CYP) enzyme activity in
healthy adult participants.
I. To determine the modulation effect on phase II detoxification enzymes. II. To evaluate
safety in participants treated with this drug.
Participants receive oral resveratrol once daily for 4 weeks.
Patients complete a daily diary documenting adverse events and an intake calendar for
recording the daily intake of any non-routine medications.
Participants undergo blood sample collection periodically. Lymphocytes are isolated and
analyzed for baseline GST activity and level. Serum is analyzed to determine bilirubin
levels to be used as surrogate UGT 1A1 activity. Analyses of CYP probe drugs will be
performed using high performance liquid chromatography (HPLC) assays. A sensitive ELISA
assay will be used for quantitative analyses. Urine samples are collected periodically and
drug and metabolite levels will be analyzed.
After completion of study treatment, participants are followed for 2 weeks.
Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Modulation of CYP enzyme activities
Will be assessed by a comparison of CYP enzyme activities from baseline to end of resveratrol intervention. CYP1A2, 2D6, 2C9, and 3A4 activity will be assessed by plasma paraxanthine/caffeine ratio, urinary dextromethorphan/dextrophan ratio, urinary losartan/losartan metabolite ratio, and area under the plasma buspirone concentration-time curve, respectively. The primary analysis will consist of paired t-tests of differences in log values from baseline to end of intervention (equivalent to log of the ratio).
From baseline to end of resveratrol intervention
Hsiao-Hui (Sherry) Chow
Arizona Cancer Center - Tucson
United States: Food and Drug Administration
|Arizona Cancer Center - Tucson||Tucson, Arizona 85724-5024|