Clinical trial NCT01825707: AME Study of [14C]-YH4808 in Healthy Male Subjects
Official title: A Phase I Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-YH4808 Following Single Oral Dose Administration in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2013-04-08
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

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 \[Day 11\]).

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

Primary outcomes:
measure: PK of a single oral dose of [14C] YH4808 200 mg and its metabolites(M3, M8)
timeFrame: Day1-Day11
Secondary outcomes:
measure: Characterization and identification of metabolites of [14C]-YH4808 in plasma, urine, and feces
timeFrame: Day1-Day11
measure: assessment of the safety and tolerability of YH4808
timeFrame: Day1-Day11
Other outcomes:
Locations:
city: Madison
country: United States
facility: Covance Clinical Research Unit
state: Wisconsin
Study officials:
affiliation: Covance Clinical Research Unit
name: Nicholas Siebers, M.D.
role: PRINCIPAL_INVESTIGATOR
References: