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 range

18 Years – 50 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-12

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