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

NCT ID: NCT01825707

Last Updated: 2014-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2013-03-31

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]).

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

[14C]-YH4808 200 mg

\[14C\]-YH4808 200 mg

Group Type: EXPERIMENTAL

[14C]-YH4808 200 mg

Intervention Type: DRUG

\[14C\]-YH4808 200 mg (oral) on day1

Interventions

[14C]-YH4808 200 mg

\[14C\]-YH4808 200 mg (oral) on day1

Intervention Type: DRUG

Other Intervention Names

YH4808 200 mg (100 µCi)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Yuhan Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicholas Siebers, M.D.

Role: PRINCIPAL_INVESTIGATOR

Covance Clinical Research Unit

Locations

Covance Clinical Research Unit

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

YH4808-103

Identifier Type: -

Identifier Source: org_study_id