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Absorption, Metabolism, and Excretion of (-)-[2-14C]Epicatechin in Humans

NCT01969994 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2013-10-25

No results posted yet for this study

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.

Conditions

  • ADME

Interventions

OTHER

Controlled dietary background

Controlled dietary flavanol-/procyanidin- background, consisting of daily intake for 14 days (day -17 to -4) of a commercially available flavanol-/procyanidin-containing cocoa-based drink (250 mg cocoa flavanols; 40 mg of (-)-epicatechin) followed by a 4-day period (day -4 to 0) of a low-flavanol diet.

OTHER

(-)-[2-14C]epicatechin intake

Single oral intake of an aqueous solution of a mixture of non-radiolabeled (-)-epicatechin and a single-carbon-14 radiolabeled (-)-\[2-14C\]epicatechin. The target amount of EC delivered with test drink will be 60 mg, 58.5 mg of which consist of non-radiolabled EC and 1.54 mg (300 µCi) consist of (-)-\[2-14C\]epicatechin.

Sponsors & Collaborators

  • Covance

    collaborator INDUSTRY

  • Mars, Inc.

    collaborator INDUSTRY

  • The Institutes for Pharmaceutical Discovery, LLC

    lead INDUSTRY

Principal Investigators

  • Christine L Hale, MD · Covance Clinical Pharmacology Inc.

  • Michael Fare · IPD, LLC

  • Javier I Ottaviani, Ph.D. · Mars, Inc.

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01969994 on ClinicalTrials.gov