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 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT00287833
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00287833
Study Brief:
Protocol Section:
NCT00287833