Absorption, Metabolism, and Excretion of (-)-[2-14C]Epicatechin in Humans
Completed · Not applicable
Conditions studied: ADME
In brief
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.
Key facts
- Study ID
- NCT01969994
- Run by
- The Institutes for Pharmaceutical Discovery, LLC
- People needed
- 12
- Starts
- 2009-12-01
- Expected to finish
- 2009-12-01
- Last updated by the study team
- 2013-10-25
Who can join
Age: 18 and older, up to 50. Sex: male. Healthy volunteers: accepted.
You may not qualify if…
- 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;
- 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;
- use of any alcohol-containing or caffeine-containing products/medications within 72 hours prior to (-)-[2-14C]epicatechin ingestion;
- regular consumption of more than 2 alcoholic drinks per day;
- vegans, vegetarians and/or anyone who consumed less than 1 to 2 servings of fruits and or vegetables per day;
- 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;
Where it is running
- Covance Clinical Pharmacology Inc. — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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