NCT01825707

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

A Phase I Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-YH4808 Following Single Oral Dose Administration in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Yuhan Corporation · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to Study Entry (ie, prior to Check-in \[Day -1\]). Subjects will be confined at the Clinical Research Unit (CRU) from Check in (Day -1) until Discharge Criteria have been met (as early as Day 6 and as late as Day 11). In this study design, physical examinations, electrocardiograms (ECGs), vital signs, How do you feel? (HDYF?) Inquiries, and clinical laboratory evaluations will be performed at Screening, at specified times during the study, and/or at Clinic Discharge. All AEs, whether volunteered, elicited, or noted on physical examination, will be recorded throughout the study (ie, from dosing on Day 1 until Clinic Discharge \[Day 11\]).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	[14C]-YH4808 200 mg	\[14C\]-YH4808 200 mg (oral) on day1

Timeline

• Start date: 2013-01-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2013-04-08
• Last updated: 2014-07-14

Locations

1 site across 1 country: United States