Healthy, no Evidence of Disease Clinical Trial
Official title:
Clinical Study of Resveratrol on Drug and Carcinogen Metabolizing Enzymes
Resveratrol may prevent cancer in healthy people. Studying samples of blood and urine in the laboratory from participants who are taking resveratrol may help doctors learn more about how this drug is used by the body. This phase I trial is studying the side effects of resveratrol and to see how it works in healthy adult participants.
PRIMARY OBJECTIVES:
I. To determine the effect of resveratrol on human cytochrome P450 (CYP) enzyme activity in
healthy adult participants.
SECONDARY OBJECTIVES:
I. To determine the modulation effect on phase II detoxification enzymes. II. To evaluate
safety in participants treated with this drug.
OUTLINE:
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.
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Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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