Phase I Single Dose Safety and Pharmacokinetic Study 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 Bowman Birk Inhibitor Concentrate, Delivered as an Orange Juice Suspension to Healthy Male Volunteers Between 18 and 65 Years of Age
PRIMARY OBJECTIVES:
I. Determine the toxic effects of Bowman-Birk inhibitor concentrate, administered as an
orange juice suspension, in healthy male participants.
II. Determine a safe dose range of this drug in these participants. III. Determine a
recommended phase II dose of this drug in these participants.
SECONDARY OBJECTIVES:
I. Determine the pharmacokinetics of this drug in these participants.
OUTLINE: This is a randomized, placebo-controlled, double-blind, dose-escalation study.
Participants are sequentially assigned to 1 of 4 dose level cohorts. One participant in each
dose level cohort is randomized to receive placebo. Participants receive 1 of 4 escalating
doses of oral Bowman-Birk inhibitor concentrate or placebo, as an orange juice suspension,
on day 1.
After completion of study treatment, participants are followed periodically for 4 weeks.
Inclusion Criteria:
- Healthy volunteer
- Male
- Performance status - ECOG 0-2
- RBC normal
- WBC ≥ 3,000/mm^3
- Platelet count normal
- Hemoglobin normal
- Hematocrit normal
- ALT and AST normal
- Bilirubin normal
- Creatinine normal
- No history of heart disease
- EKG normal
- No history of pancreatitis or obstruction of pancreatic ducts
- No history of pancreatic cancer or pancreatic adenoma
- Amylase normal
- Lipase normal
- Cholesterol normal
- Triglycerides normal
- Serum glucose ± 10% of normal
- Within 15% of ideal body weight
- No history of chronic medical condition
- No history of excessive alcohol consumption (i.e., > 2 alcoholic beverages per day on
average)
- No history of amyloidosis
- Non-smoker
- Former smokers are eligible provided they have not smoked within the past 3
months
- No history of medical condition that would influence gastrointestinal uptake of the
study drug
- No history of diabetes mellitus
- No allergy or prior adverse reaction to soybeans
- Not a vegetarian
- No diagnosis of cancer within the past 5 years except nonmelanoma skin cancer
- No evidence of other life-threatening disease
- No evidence of psychiatric problems
- More than 12 months since prior chemotherapy
- More than 1 month since prior experimental drugs
- More than 3 days since prior consumption of alcoholic beverages
- More than 2 weeks since prior and no concurrent regular use (i.e., > 3 times/week) of
nonsteroidal anti-inflammatory drugs
- More than 2 weeks since prior multivitamin tablets (or other vitamin supplements) of
> 2 per day
- No more than 2 multivitamin tablets (or other vitamin supplements) per day during
study participation
- No more than 1 serving of tofu, soy milk, or other primarily soy-based food per day
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Outcome Measure:
Safety as measured by NCI Common Toxicity Criteria and a recommended Phase II dose (RPTD)
Outcome Time Frame:
Up to 4 weeks
Safety Issue:
Yes
Principal Investigator
Robert Lustig
Investigator Role:
Principal Investigator
Investigator Affiliation:
Abramson Cancer Center of the University of Pennsylvania
Authority:
United States: Food and Drug Administration
Study ID:
NCI-2011-01479
NCT ID:
NCT00287833
Start Date:
January 2006
Completion Date:
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
Name | Location |
|---|---|
| Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |
