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
1 other identifier
interventional
8
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started Jan 2013
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 14, 2013
CompletedFirst Posted
Study publicly available on registry
April 8, 2013
CompletedJuly 14, 2014
July 1, 2014
2 months
March 14, 2013
July 11, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Characterization and identification of metabolites of [14C]-YH4808 in plasma, urine, and feces
Day1-Day11
assessment of the safety and tolerability of YH4808
Day1-Day11
Study Arms (1)
[14C]-YH4808 200 mg
EXPERIMENTAL\[14C\]-YH4808 200 mg
Interventions
\[14C\]-YH4808 200 mg (oral) on day1
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Covance Clinical Research Unit
Madison, Wisconsin, 53704, United States
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Nicholas Siebers, M.D.
Covance Clinical Research Unit
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2013
First Posted
April 8, 2013
Study Start
January 1, 2013
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
July 14, 2014
Record last verified: 2014-07