Finding studies
Finding studies
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Lead
National Cancer Institute (NCI)
PRIMARY OBJECTIVES: I. Determine the toxic effects of Bowman-Birk inhibitor concentrate, administered as an orange juice suspension, in healthy male participants. II. Determine a safe dose range of this drug in these participants. III. Determine a recommended phase II dose of this drug in these participants. SECONDARY OBJECTIVES: I. Determine the pharmacokinetics of this drug in these participants. OUTLINE: This is a randomized, placebo-controlled, double-blind, dose-escalation study. Participants are sequentially assigned to 1 of 4 dose level cohorts. One participant in each dose level cohort is randomized to receive placebo. Participants receive 1 of 4 escalating doses of oral Bowman-Birk inhibitor concentrate or placebo, as an orange juice suspension, on day 1. After completion of study treatment, participants are followed periodically for 4 weeks.
Age
18–65
Sex
MALE
Healthy volunteers
Accepted
