Phase I Single Dose Safety and Pharmacokinetic Study of a New Formulation of Bowman Birk Inhibitor Concentrate, Delivered as an Orange Juice Suspension to Healthy Male Volunteers Between 18 and 65 Years of Age
I. Assess the toxicity of single-dose Bowman-Birk Inhibitor Concentrate (BBIC) when
administered as a suspension in orange juice in healthy male participants.
II. Determine the appropriate dose range and doses to be used in a subsequent phase I
multiple-dose BBIC study that will be based upon the data gathered from this phase I
III. Characterize the pharmacokinetics of single-dose BBIC.
OUTLINE: This is a dose-escalation study of Bowman-Birk Inhibitor Concentrate (BBIC).
Participants are sequentially assigned to 1 of 4 dose level cohorts. One participant in each
dose level cohort is randomized to receive placebo or BBIC.
Participants receive a single dose of oral BBIC or placebo, as an orange juice suspension,
immediately followed by consumption of a defined low-fat breakfast. Participants continue to
consume a low-fat diet for the next 48 hours and then resume their normal diet.
Participants undergo blood and urine sample collection periodically for pharmacokinetic
studies. Samples are analyzed by a sandwich enzyme-linked immunosorbent assay to measure
concentrations of BBIC and its metabolites in serum and urine.
After completion of study treatment, participants are followed once weekly for 4 weeks.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Recommended phase II dose, defined as the highest dose level at which none of the subjects in that dose group experience DLT as measured by NCI Common Toxicity Criteria
Up to 48 hours
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|