Lycopene in Healthy Male Participants

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.

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