NCT00450957

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Healthy, no Evidence of Disease
• Prostate Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	lycopene	Given orally
OTHER	pharmacological study	Correlative studies

Timeline

• Start date: 2006-10-01
• Primary completion: 2007-11-01
• Completion: 2007-11-01
• First posted: 2007-03-22
• Last updated: 2015-04-15

Locations

1 site across 1 country: United States