Bowman-Birk Inhibitor Concentrate in Healthy Men

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Healthy, no Evidence of Disease

Intervention / Treatment
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* Drug: Bowman-Birk inhibitor concentrate
* Other: placebo
* Other: pharmacological study
* Other: laboratory biomarker analysis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>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. | Drug: Bowman-Birk inhibitor concentrate<br>* Given orally<br>* Other names: BBIC;Other: placebo<br>* Given orally<br>* Other names: PLCB;Other: pharmacological study<br>* Correlative studies<br>* Other names: pharmacological studies;Other: laboratory biomarker analysis<br>* Correlative studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Pharmacokinetics of BBIC in the serum as measured by a sandwich enzyme-linked immunosorbent assay | Presented in a form of time course of serum BBI concentration after BBIC ingestion by the study subjects and peak concentration (Cmax), time to reach peak concentration (Tmax), area under the curve (AUC), and elimination rate constant (kel) and serum half-lives (t1/2) will be calculated for each subject. Mean, median, and 95% confidence interval will then be calculated for each parameter for each dose group. The relationship between dose and the above parameters will be investigated using simple linear regression. | Immediately before BBIC administration and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, and 48 after administration |