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

Yuhan

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: [14C]-YH4808 200 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01825707

YH4808-103

Details and patient eligibility

About

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.

Full 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]).

Enrollment: 8 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

8 participants in 1 patient group

[14C]-YH4808 200 mg

Experimental group

Description:

\[14C\]-YH4808 200 mg

Treatment:

Drug: [14C]-YH4808 200 mg