Clinical trial · Interventional
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
NCT00287833CI-TRIAL-00010196completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This randomized phase I trial is studying the side effects and best dose of Bowman-Birk inhibitor concentrate in preventing cancer in healthy men. Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of Bowman-Birk inhibitor concentrate may prevent cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bowman-Birk inhibitor concentrate | Drug | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (Bowman-Birk inhibitor concentrate)
- description
- 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.
- interventionNames
- Drug: Bowman-Birk inhibitor concentrate
- type
- PLACEBO_COMPARATOR
- label
- Arm II (placebo)
- description
- 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.
- interventionNames
- Other: placebo
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.