Lycopene in Healthy Male Participants

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

This randomized phase I trial is studying the side effects and best dose of lycopene in healthy male participants. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of lycopene, a substance found in tomatoes, may prevent prostate cancer.

OBJECTIVES: I. Compare the toxicity and safety of 2 different doses of oral lycopene in healthy male participants. 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 treatment arms. 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 pharmacokinetic sampling. Blood samples are collected periodically at baseline and during study treatment for pharmacokinetic studies. PROJECTED ACCRUAL: A total of 20 participants will be accrued for this study.

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.

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

Inclusion Criteria: Healthy volunteers judged to be in good medical condition based on history and physical exam Karnofsky performance status 100% AST and ALT ≤ 75 IU/L Bilirubin ≤ 2.0 mg/dL Creatinine ≤ 1.5 mg/dL Hemoglobin ≥ 13.0 g/dL WBC ≥ 4,000/mm³ Platelet count ≥ 150,000/mm³ and ≤ 400,000/mm³ Must be within height and weight standards identified by Metropolitan Life scales Nonsmoker (for ≥ 3 months) No history of alcohol abuse No history of gastrointestinal malabsorption or other condition that could affect drug absorption No history of a psychiatric condition No chronic medical condition No active history of any of the following: Cancer Liver disease Cardiovascular disease Renal disease Diabetes mellitus Other illnesses that, in the opinion of the investigator, could represent a threat for the participants life No allergy to tomato-based products No lycopene in the diet for ≥ 14 days At least 4 weeks since prior and no other concurrent experimental medications No concurrent participation in another experimental study No concurrent use of regular prescription medication or over-the-counter medications No concurrent vitamin, mineral, or herbal supplements