Status:
COMPLETED
AME Study of [14C]-YH4808 in Healthy Male Subjects
Lead Sponsor:
Yuhan Corporation
Conditions:
Healthy
Eligibility:
MALE
18-55 years
Phase:
PHASE1
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 fo...
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 Res...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01825707
Start Date
January 1 2013
End Date
March 1 2013
Last Update
July 14 2014
Active Locations (1)
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1
Covance Clinical Research Unit
Madison, Wisconsin, United States, 53704