Bowman-Birk Inhibitor Concentrate in Healthy Men

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2009-12-31

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.

Conditions

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Healthy, no Evidence of Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm I

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.

Group Type EXPERIMENTAL

Bowman-Birk inhibitor concentrate

Intervention Type DRUG

Given orally

placebo

Intervention Type OTHER

Given orally

pharmacological study

Intervention Type OTHER

Correlative studies

laboratory biomarker analysis

Intervention Type OTHER

Correlative studies

Interventions

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Bowman-Birk inhibitor concentrate

Given orally

Intervention Type DRUG

placebo

Given orally

Intervention Type OTHER

pharmacological study

Correlative studies

Intervention Type OTHER

laboratory biomarker analysis

Correlative studies

Intervention Type OTHER

Other Intervention Names

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BBIC PLCB pharmacological studies

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lilie Lin

Role: PRINCIPAL_INVESTIGATOR

Abramson Cancer Center at Penn Medicine

Locations

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Abramson Cancer Center of The University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States