Healthy, no Evidence of Disease Clinical Trial
Official title:
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
This randomized phase I trial is studying the side effects and best dose of Bowman-Birk inhibitor concentrate in healthy men. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of Bowman-Birk inhibitor concentrate may prevent cancer.
OBJECTIVES:
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
single-dose study.
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
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