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.

Inclusion Criteria:

• Healthy male participant recruited from the Philadelphia, Pennsylvania metropolitan area

• ECOG performance status 0-2

• WBC ≥ 3,000/uL

• Differential (i.e., neutrophils, lymphocytes, monocytes, bands, eosinophils, and basophils) normal

• Platelet count normal

• Hemoglobin normal

• Hematocrit normal

• RBC normal

• Creatinine normal

• Bilirubin normal

• ALT and AST normal

• Amylase and lipase normal

• Glucose normal

• Cholesterol normal

• Triglycerides normal

• Non-smoker

  • Former smokers are eligible provided they have not smoked within the past 3 months

• Within 15% of ideal body weight based on standard weight tables

• No vegetarians or individuals who normally ingest large amounts of soy products, defined as two or more servings of tofu, soy milk, or other primarily soy-based food per day

• No prior allergy or adverse reaction to soybeans

• No diagnosis of cancer within the past 5 years except nonmelanoma skin cancer

• No prior diagnosis of pancreatitis, pancreatic carcinoma, pancreatic adenoma, diabetes mellitus, obstruction of pancreatic ducts, or amyloidosis

• No history of heart disease

• EKG normal (normal variants allowed)

• No evidence of psychiatric problems

• No history of excessive alcohol consumption (i.e., an average of > 2 alcoholic beverages per day)

• No alcohol consumption within the past 3 days

• No history of any medical condition that could influence gastrointestinal uptake of the drug

• No history of chronic medical condition

• No evidence of another life-threatening disease

• More than 12 months since prior chemotherapy

• More than 1 month since prior experimental drugs

• More than 2 weeks since prior and no concurrent regular use (i.e., > 3 times/week) of nonsteroidal anti-inflammatory drugs (NSAIDs)

• More than 2 weeks since prior and no concurrent multivitamin tablets (or other vitamin supplements) of > 2 per day