Phase I Single Dose Safety and Pharmacokinetic Study of Bowman Birk Inhibitor Concentrate, Delivered as an Orange Juice Suspension to Healthy Male Volunteers Between 18 and 65 Years of Age
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.
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.
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Safety as measured by NCI Common Toxicity Criteria and a recommended Phase II dose (RPTD)
Up to 4 weeks
Abramson Cancer Center of the University of Pennsylvania
United States: Food and Drug Administration
|Abramson Cancer Center of the University of Pennsylvania||Philadelphia, Pennsylvania 19104-4283|