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
18 Years
65 Years
Male
Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Outcome 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
Outcome Time Frame:
Up to 48 hours
Safety Issue:
Yes
Principal Investigator
Lilie Lin
Investigator Role:
Principal Investigator
Investigator Affiliation:
Abramson Cancer Center of the University of Pennsylvania
Authority:
United States: Food and Drug Administration
Study ID:
NCI-2009-00865
NCT ID:
NCT00679094
Start Date:
June 2007
Completion Date:
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
Name | Location |
|---|---|
| Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |
