Phase I Single Dose Pharmacokinetic Study of the Dietary Supplement Lycopene Delivered in Capsule Form to Healthy Male Volunteers Between 18 and 45 Years of Age
- Determine the toxicity and safety of lycopene supplementation as chemoprevention for
prostate cancer in healthy participants.
- Determine the pharmacokinetics of this agent in these participants.
- Determine the dose range of this agent in these participants.
OUTLINE: This is a dose-escalation study.
Participants ingest a single-dose of oral lycopene over a maximum of 15 minutes on day 1.
Cohorts of 5 participants receive escalating doses of lycopene until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 5
participants experience dose-limiting toxicity.
Participants are evaluated periodically for 28 days.
PROJECTED ACCRUAL: A total of 25 participants will be accrued for this study.
Primary Purpose: Prevention
Toxicity by blood chemistries and patient histories at 4 weeks after treatment
Keith A. Rodvold
University of Illinois
United States: Federal Government
|University of Illinois at Chicago Cancer Center||Chicago, Illinois 60612|