Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 1:38 AM
NCT ID:
NCT00679094
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
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00679094
Study Brief:
Protocol Section:
NCT00679094