- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00287833
Bowman-Birk Inhibitor Concentrate in Preventing Cancer in Healthy Men
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
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Abramson Cancer Center of the University of Pennsylvania
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm I (Bowman-Birk inhibitor concentrate)
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.
|
Given orally
Other Names:
|
Placebo Comparator: Arm II (placebo)
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.
|
Given orally
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety as measured by NCI Common Toxicity Criteria and a recommended Phase II dose (RPTD)
Time Frame: Up to 4 weeks
|
Up to 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics measurements of BBI in the blood and urine
Time Frame: 0 (immediately prior to BBIC administration), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, and 48 hours after BBIC administration
|
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.
|
0 (immediately prior to BBIC administration), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, and 48 hours after BBIC administration
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Robert Lustig, Abramson Cancer Center of the University of Pennsylvania
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- NCI-2011-01479
- UPCC-706366
- N01-CN-25118
- CDR0000429594
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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