Lycopene in Healthy Male Participants

Launched by NATIONAL CANCER INSTITUTE (NCI) · Mar 20, 2007

Keywords

ClinConnect Summary

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 crossove...

Gender

MALE

Eligibility criteria

• 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