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.
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.
- Healthy male participant recruited from the Philadelphia, Pennsylvania metropolitan
- ECOG performance status 0-2
- WBC ≥ 3,000/uL
- Differential (i.e., neutrophils, lymphocytes, monocytes, bands, eosinophils, and
- 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
- Former smokers are eligible provided they have not smoked within the past 3
- 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
- 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
- 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