Lycopene in Healthy Male Participants

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Healthy, no Evidence of Disease, Prostate Cancer

Intervention / Treatment
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* Dietary Supplement: lycopene
* Other: pharmacological study


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (high-dose lycopene)<br>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. | Dietary Supplement: lycopene<br>* Given orally<br>* Other names: psi,psi-Carotene;Other: pharmacological study<br>* Correlative studies<br>* Other names: pharmacological studies;|
| Experimental: Arm II (low-dose lycopene)<br>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 | Dietary Supplement: lycopene<br>* Given orally<br>* Other names: psi,psi-Carotene;Other: pharmacological study<br>* Correlative studies<br>* Other names: pharmacological studies;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity according to NCI Common Toxicity Criteria (CTC) version 3.0 |  | 2 weeks | 
| Safety according to NCI CTC version 3.0 |  | 12 weeks | 
| Pharmacokinetics |  | At baseline, at 12, 24, 36, 48, 72, 96, 120, 168, 216, 288, and 360 hours |