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 @ 1:42 AM
Ignite Modification Date:
2025-12-25 @ 1:42 AM
NCT ID:
NCT01969994
Eligibility Criteria:
Inclusion Criteria1.
1. males, in good health, between 18 and 50 years of age and between 60 and 100 kg;
2. body mass index (BMI) between 19 and 30 kg/m2.
3. clinical laboratory evaluations (including clinical chemistry \[fasted at least 10 hours\], hematology, and urinalysis) within the reference range for the testing laboratory, unless deemed not clinically significant by the Investigator;
4. negative hepatitis panel (including hepatitis B surface antigen \[HbsAg\] and hepatitis C virus antibody \[anti-HCV\]) and human immunodeficiency virus (HIV) antibody screens;
5. a minimum of 1 bowel movement per day.
Exclusion Criteria:
1. history or clinical manifestations of significant metabolic, hematological, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urological, or psychiatric disorders;
2. allergies to peanuts, nuts, or other foods;
3. lactose intolerance;
4. history of stomach or intestinal surgery, except that appendectomy or hernia were allowed;
5. history of alcoholism or drug addiction within 1 year prior to study entry (ie, at Screening);
6. use of any tobacco products (including cigarette, pipe, cigar, chewing, nicotine patch, or nicotine gum) within 6 months prior to study entry;
7. use of any agents (excluding those provided as part of this study procedure) affecting the liver enzymes;
8. use of aspirin-containing drugs and any other over-the-counter, non-prescription preparations (including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations) during the study, unless deemed acceptable by the Investigator;
9. use of any alcohol-containing or caffeine-containing products/medications within 72 hours prior to (-)-\[2-14C\]epicatechin ingestion;
10. regular consumption of more than 2 alcoholic drinks per day;
11. vegans, vegetarians and/or anyone who consumed less than 1 to 2 servings of fruits and or vegetables per day;
12. participation in more than one other radiolabeled investigational study drug trial within 12 months prior to study entry or exposure to significant radiation within 12 months prior to study entry;
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01969994
Study Brief:
Protocol Section:
NCT01969994