Bowman-Birk Inhibitor Concentrate in Healthy Men
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria:
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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
Trial design
Primary purpose
Allocation
Interventional model
Masking
20 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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