PHASE I SINGLE &MULTIPLE DOSE SAFETY &PHARMACOKINETICS

University Of Illinois At Chicago, Chicago IL

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Abstract

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.