Clinical trial NCT00679094: Bowman-Birk Inhibitor Concentrate in Healthy Men
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy, no Evidence of Disease
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2008-05-16
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: Up to 48 hours
measure: Pharmacokinetics of BBIC in the serum as measured by a sandwich enzyme-linked immunosorbent assay
timeFrame: Immediately before BBIC administration and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, and 48 after administration
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of The University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Lilie Lin
role: PRINCIPAL_INVESTIGATOR
References: