AME Study of [14C]-YH4808 in Healthy Male Subjects

Completed · Phase 1

Conditions studied: Healthy

In brief

The purpose of this study is to determine the absorption, metabolism, and excretion (AME) kinetics of YH4808 and to determine and characterize metabolites present in plasma, urine, and feces in man following a single dose of \[14C\] YH4808 200 mg (\~100 µCi ±20 µCi) administered as a single oral dose.

Key facts

Study ID

NCT01825707

Run by

Yuhan Corporation

People needed

8

Starts

2013-01-01

Expected to finish

2013-03-01

Last updated by the study team

2014-07-14

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• clinical laboratory evaluations within the reference range for the test laboratory
• negative test for selected drugs of abuse, hepatitis panel and HIV antibody screens
• able to comprehend and willing to sign an Informed Consent Form

You may not qualify if…

• significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
• history of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
• participation in more than 1 other radiolabeled investigational study drug trial within 12 months prior to Check-in
• donation of blood from 30 days prior to Screening through Study Completion, inclusive, or of plasma from 2 weeks prior to Screening through Study Completion, inclusive

Where it is running

• Covance Clinical Research Unit — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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