Bowman-Birk Inhibitor Concentrate in Healthy Men

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy, no Evidence of Disease
• Intervention / Treatment: Other: laboratory biomarker analysis; Other: pharmacological study; Other: placebo; Drug: Bowman-Birk inhibitor concentrate

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Abramson Cancer Center of the University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: DOUBLE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Other: laboratory biomarker analysis; Correlative studies; Other: pharmacological study; Correlative studies; Other Names: pharmacological studies; Other: placebo; Given orally; Other Names: PLCB; Drug: Bowman-Birk inhibitor concentrate; Given orally; Other Names: BBIC

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Lilie Lin, Abramson Cancer Center of the University of Pennsylvania

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (ACTUAL): December 1, 2009
• Study Completion (ACTUAL): December 1, 2009

Study Registration Dates

• First Submitted: May 14, 2008
• First Submitted That Met QC Criteria: May 14, 2008
• First Posted (ESTIMATE): May 16, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): December 29, 2016
• Last Update Submitted That Met QC Criteria: December 28, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: NCI-2009-00865 (REGISTRY: CTRP (Clinical Trial Reporting Program)); CDR0000595863; UPCC-N01-CN-25118-2; UPCC-805938 (OTHER: Abramson Cancer Center of The University of Pennsylvania); N01-CN-25118-2 (OTHER: DCP); P30CA016520 (U.S. NIH Grant/Contract); N01CN25118 (OTHER: US NIH Grant/Contract Award Number)