Healthy Subjects Clinical Trial
Official title:
An Open Label Study to Evaluate the Pharmacokinetics of ASP3652 After a Single Oral Dose of 14C-labeled ASP3652 in Healthy Caucasian Male Subjects
This study measures how much of the trial drug enters the body and how long it takes for the body to remove it via the feces and urine. In addition, the different breakdown products after a single oral dose of radio-active ASP3652 will be identified.
This is an open-label, one-period, single-dose study with 14C labeled ASP3652.
Screening takes place between Day 22 to Day 2, and subjects are admitted to the clinic on
Day -1.
On the morning of Day 1, each subject receives a single oral dose of 14C-labeled ASP3652.
Blood, urine and feces samples for analysis of 14C radioactivity are collected until at
least 120 h after dosing. Blood samples for the analysis of ASP3652 and metabolites are
collected until 120 h after dosing.
The subjects remain in the clinic until Day 6 (or up to Day 13 in case discharge criteria
are not met on Day 6) and return for an End of Study Visit (ESV) 7 to 14 days after (early)
discharge.
;
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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