Phase I Multiple Dose Pharmacokinetic Study of the Dietary Supplement Lycopene Delivered in Capsule Form to Healthy Male Volunteers Between 18 and 55 Years of Age
I. Compare the toxicity and safety of 2 different doses of oral lycopene in healthy male
II. Compare the pharmacokinetics of 2 different doses of this drug in these participants.
III. Determine the toxicity and pharmacokinetics needed to proceed to a large phase II/III
study in men at high risk for prostate cancer.
OUTLINE: This is a randomized, crossover study. Participants are randomized to 1 of 2
Arm I: Participants receive high-dose oral lycopene once or twice a day for 14 days. After 2
weeks of a lycopene-free period, participants crossover and receive high-dose lycopene at
the alternative daily schedule (once or twice a day) for 14 days.
Arm II: Participants receive low-dose oral lycopene once or twice a day for 14 days. After 2
weeks of a lycopene-free period, participants crossover and receive low-dose lycopene at the
alternative daily schedule (once or twice a day) for 14 days.
Treatment continues in the absence of unacceptable toxicity. Participants adhere to dietary
restrictions for 2 weeks at baseline, 2 weeks during study treatment, and 2 weeks during
Blood samples are collected periodically at baseline and during study treatment for
PROJECTED ACCRUAL: A total of 20 participants will be accrued for this study.
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Toxicity according to NCI Common Toxicity Criteria (CTC) version 3.0
University of Illinois
United States: Food and Drug Administration
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