Bowman-Birk Inhibitor Concentrate in Healthy Men
- Conditions
- Healthy, no Evidence of Disease
- Interventions
- Drug: Bowman-Birk inhibitor concentrateOther: placeboOther: pharmacological studyOther: laboratory biomarker analysis
- Registration Number
- NCT00679094
- Lead Sponsor
- National Cancer Institute (NCI)
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 20
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Healthy male participant recruited from the Philadelphia, Pennsylvania metropolitan area
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ECOG performance status 0-2
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WBC ≥ 3,000/uL
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Differential (i.e., neutrophils, lymphocytes, monocytes, bands, eosinophils, and basophils) normal
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Platelet count normal
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Hemoglobin normal
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Hematocrit normal
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RBC normal
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Creatinine normal
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Bilirubin normal
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ALT and AST normal
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Amylase and lipase normal
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Glucose normal
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Cholesterol normal
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Triglycerides normal
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Non-smoker
- Former smokers are eligible provided they have not smoked within the past 3 months
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Within 15% of ideal body weight based on standard weight tables
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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
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No prior allergy or adverse reaction to soybeans
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No diagnosis of cancer within the past 5 years except nonmelanoma skin cancer
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No prior diagnosis of pancreatitis, pancreatic carcinoma, pancreatic adenoma, diabetes mellitus, obstruction of pancreatic ducts, or amyloidosis
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No history of heart disease
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EKG normal (normal variants allowed)
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No evidence of psychiatric problems
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No history of excessive alcohol consumption (i.e., an average of > 2 alcoholic beverages per day)
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No alcohol consumption within the past 3 days
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No history of any medical condition that could influence gastrointestinal uptake of the drug
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No history of chronic medical condition
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No evidence of another life-threatening disease
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More than 12 months since prior chemotherapy
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More than 1 month since prior experimental drugs
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More than 2 weeks since prior and no concurrent regular use (i.e., > 3 times/week) of nonsteroidal anti-inflammatory drugs (NSAIDs)
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More than 2 weeks since prior and no concurrent multivitamin tablets (or other vitamin supplements) of > 2 per day
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm I Bowman-Birk inhibitor concentrate 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. Arm I pharmacological study 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. Arm I laboratory biomarker analysis 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. Arm I placebo 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.
- Primary Outcome Measures
Name Time Method Pharmacokinetics of BBIC in the serum as measured by a sandwich enzyme-linked immunosorbent assay Immediately before BBIC administration and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, and 48 after administration 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.
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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Abramson Cancer Center of The University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States