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:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-24 @ 6:55 PM
NCT ID:
NCT00450957
Eligibility Criteria:
Inclusion Criteria:
* Healthy volunteers judged to be in good medical condition based on history and physical exam
* Karnofsky performance status 100%
* AST and ALT ≤ 75 IU/L
* Bilirubin ≤ 2.0 mg/dL
* Creatinine ≤ 1.5 mg/dL
* Hemoglobin ≥ 13.0 g/dL
* WBC ≥ 4,000/mm³
* Platelet count ≥ 150,000/mm³ and ≤ 400,000/mm³
* Must be within height and weight standards identified by Metropolitan Life scales
* Nonsmoker (for ≥ 3 months)
* No history of alcohol abuse
* No history of gastrointestinal malabsorption or other condition that could affect drug absorption
* No history of a psychiatric condition
* No chronic medical condition
* No active history of any of the following:
* Cancer
* Liver disease
* Cardiovascular disease
* Renal disease
* Diabetes mellitus
* Other illnesses that, in the opinion of the investigator, could represent a threat for the participants life
* No allergy to tomato-based products
* No lycopene in the diet for ≥ 14 days
* At least 4 weeks since prior and no other concurrent experimental medications
* No concurrent participation in another experimental study
* No concurrent use of regular prescription medication or over-the-counter medications
* No concurrent vitamin, mineral, or herbal supplements
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT00450957
Study Brief:
Protocol Section:
NCT00450957