Phase I Single-Dose Safety and Phamacokinetics Clinical Study of Resveratrol AKA IRB 2003-424
- Determine the concentration of resveratrol and its metabolites in the plasma, urine,
and feces of healthy participants.
- Correlate dose with systemic concentration of this drug and its metabolites in these
- Determine the safety of this drug in these participants.
OUTLINE: This is an open-label, dose-escalation, multicenter study.
Beginning 5 days before study drug administration, participants are put on a controlled diet
(avoiding all resveratrol-containing food or drink) for washout. Participants receive oral
resveratrol once on day 1.
Cohorts of 10 participants receive escalating doses of resveratrol until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2
of 10 participants experience dose-limiting toxicity. A total of 16 participants are treated
at the MTD.
Participants are followed at 2 and 7 days.
PROJECTED ACCRUAL: A total of 10-40 participants will be accrued for this study within 6
Masking: Open Label, Primary Purpose: Prevention
Dean E. Brenner, MD
University of Michigan Cancer Center
United States: Food and Drug Administration
|University of Michigan Comprehensive Cancer Center||Ann Arbor, Michigan 48109-0752|