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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: [14C]-YH4808 200 mg

• Registration Number: NCT01825707
• Lead Sponsor: Yuhan Corporation

Brief 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 \[Day 11\]).

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Study First Submitted: 2013-03-14
• Study First Submitted QC: 2013-04-01
• Study First Posted: 2013-04-08
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-11
• Last Update Posted: 2014-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[14C]-YH4808 200 mg	[14C]-YH4808 200 mg	\[14C\]-YH4808 200 mg

Primary Outcome Measures

Name	Time	Method
PK of a single oral dose of [14C] YH4808 200 mg and its metabolites(M3, M8)	Day1-Day11	* Maximum observed concentration in plasma, whole blood, urine, and feces; * Time to maximum observed concentration in plasma, whole blood, urine, and feces; * Area under the concentration-time curve from Hour 0 to the last measurable concentration; * Assessment of Mass balance

Secondary Outcome Measures

Name	Time	Method
Characterization and identification of metabolites of [14C]-YH4808 in plasma, urine, and feces	Day1-Day11
assessment of the safety and tolerability of YH4808	Day1-Day11	* Clinical laboratory tests; * 12-lead ECGs; * Physical examinations; * Vital signs; * Adverse event assessments

Trial Locations

Locations (1)

Covance Clinical Research Unit; 🇺🇸 Madison, Wisconsin, United States