Absorption, Metabolism, and Excretion of (-)-[2-14C]Epicatechin in Humans (NCT01969994) | Clinical Trial Compass
CompletedNot Applicable
Absorption, Metabolism, and Excretion of (-)-[2-14C]Epicatechin in Humans
United States12 participantsStarted 2009-12
Plain-language summary
The purpose of this study is to determine the absorption, metabolism and excretion of (-)-epicatechin using the radiolabeled tracer (-)-\[2-14C\]epicatechin in healthy male volunteers observing a flavanol-/procyanidin-controlled background diet.
Who can participate
Age range18 Years – 50 Years
SexMALE
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Inclusion criteria
✓. males, in good health, between 18 and 50 years of age and between 60 and 100 kg;
✓. body mass index (BMI) between 19 and 30 kg/m2.
✓. 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;
✓. negative hepatitis panel (including hepatitis B surface antigen \[HbsAg\] and hepatitis C virus antibody \[anti-HCV\]) and human immunodeficiency virus (HIV) antibody screens;
✓. a minimum of 1 bowel movement per day.
Exclusion criteria
✕. history or clinical manifestations of significant metabolic, hematological, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urological, or psychiatric disorders;
✕. allergies to peanuts, nuts, or other foods;
✕. lactose intolerance;
✕. history of stomach or intestinal surgery, except that appendectomy or hernia were allowed;
✕. history of alcoholism or drug addiction within 1 year prior to study entry (ie, at Screening);
✕. use of any tobacco products (including cigarette, pipe, cigar, chewing, nicotine patch, or nicotine gum) within 6 months prior to study entry;
What they're measuring
1
Change in levels of (-)-[2-14C]epicatechin-derived radioactivity in blood, plasma, urine, and feces;
Timeframe: 0 (prior to the ingestion of (-)-[2-14C]epicatechin), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours postdose, and at every subsequent 24 hour timepoint up to 240 h or until volunteers meet discharge criteria
Trial details
NCT IDNCT01969994
SponsorThe Institutes for Pharmaceutical Discovery, LLC
. use of any agents (excluding those provided as part of this study procedure) affecting the liver enzymes;
✕. 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;