The pharmacokinetics and safety of lycopene administered both as a natural product and as a single chemical entity product will be evaluated in normal, healthy men after a single administration. Five subjects will be evaluated at each of 5 doses for both products. Based on pharmacokinetic and safety results, a 3-month, repeat-dose study will be conducted with both products. Eligible subjects will be men at high risk for the development of prostate cancer. Prostatic tissue lycopene levels and pharmacological modulation of biochemical and cellular tissue endpoints will be evaluated based on the acquisition of tissue from biopsies conducted under the normal standards of surveillance and care.

Agency
National Institute of Health (NIH)
Institute
Division of Cancer Prevention And Control (NCI)
Type
Research and Development Contracts (N01)
Project #
N01CN085081-002
Application #
6345587
Study Section
Project Start
1998-09-30
Project End
2001-09-29
Budget Start
2000-08-22
Budget End
2001-09-29
Support Year
Fiscal Year
2000
Total Cost
$1,220,533
Indirect Cost
Name
University of Illinois at Chicago
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
121911077
City
Chicago
State
IL
Country
United States
Zip Code
60612
Gustin, David M; Rodvold, Keith A; Sosman, Jeffery A et al. (2004) Single-dose pharmacokinetic study of lycopene delivered in a well-defined food-based lycopene delivery system (tomato paste-oil mixture) in healthy adult male subjects. Cancer Epidemiol Biomarkers Prev 13:850-60
Diwadkar-Navsariwala, Veda; Novotny, Janet A; Gustin, David M et al. (2003) A physiological pharmacokinetic model describing the disposition of lycopene in healthy men. J Lipid Res 44:1927-39