Bowman-Birk Inhibitor Concentrate in Healthy Men

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00679094
First received: May 14, 2008
Last updated: March 5, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Healthy, no Evidence of Disease
Drug: Bowman-Birk inhibitor concentrate
Other: placebo
Other: pharmacological study
Other: laboratory biomarker analysis
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 [ Time Frame: Up to 48 hours ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics of BBIC in the serum as measured by a sandwich enzyme-linked immunosorbent assay [ Time Frame: Immediately before BBIC administration and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, and 48 after administration ] [ Designated as safety issue: No ]
    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.


Enrollment: 20
Study Start Date: June 2007
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Bowman-Birk inhibitor concentrate
Given orally
Other Name: BBIC
Other: placebo
Given orally
Other Name: PLCB
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Other: laboratory biomarker analysis
Correlative studies

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00679094

Locations
United States, Pennsylvania
Abramson Cancer Center of The University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Investigators
Principal Investigator: Lilie Lin Abramson Cancer Center of the University of Pennsylvania
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00679094     History of Changes
Other Study ID Numbers: NCI-2009-00865, NCI-2009-00865, CDR0000595863, UPCC-N01-CN-25118-2, UPCC-805938, UPCC-805938, N01-CN-25118-2, P30CA016520, N01CN25118
Study First Received: May 14, 2008
Last Updated: March 5, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on July 28, 2014