A Study to Assess the Pharmacokinetics of ASP015K in Healthy Male Subjects
The objective of this study is to evaluate pharmacokinetics, in particular the routes of excretion and extent of metabolism of ASP015K after a single oral dose of 14C-labeled ASP015K.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||A Phase 1, Open-Label, Mass Balance Study to Evaluate the Pharmacokinetics of ASP015K After a Single Oral Dose of 14C-Labeled ASP015K in Healthy Male Subjects|
- Pharmacokinetic assessment through radiographic and high performance liquid chromatography (HPLC) analysis of blood, urine and feces samples [ Time Frame: Up to 10 days ] [ Designated as safety issue: No ]
|Study Start Date:||December 2009|
|Study Completion Date:||January 2010|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
Eligible subjects will be admitted to the clinical research unit and confined for a minimum of 8 days.
|United States, Wisconsin|
|Covance Clinical Research Unit (CCRU)|
|Madison, Wisconsin, United States, 53704|
|Study Director:||Medical Director||Astellas Pharma Global Development|