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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: [14C]-YH4808 200 mg

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 Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Covance Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [14C]-YH4808 200 mg	Drug: [14C]-YH4808 200 mg; [14C]-YH4808 200 mg (oral) on day1; Other Names: YH4808 200 mg (100 µCi)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK of a single oral dose of [14C] YH4808 200 mg and its metabolites(M3, M8)	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	Day1-Day11

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Yuhan Corporation
• Investigators: Principal Investigator: Nicholas Siebers, M.D., Covance Clinical Research Unit

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: March 14, 2013
• First Submitted That Met QC Criteria: April 1, 2013
• First Posted (Estimate): April 8, 2013

Study Record Updates

• Last Update Posted (Estimate): July 14, 2014
• Last Update Submitted That Met QC Criteria: July 11, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: YH4808-103