A Study to Find Out How YM150 is Absorbed Into and Eliminated From the Body in Healthy Male Subjects
The study aims to observe how YM150 was absorbed, distributed and excreted after dosing with a radio labeled drinking solution.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||An Open Label Study to Evaluate the Pharmacokinetics of YM150 After a Single Oral Dose of C14-labeled YM150 in Healthy Male Subjects|
- Pharmacokinetics of 14C-labeled YM150 assessed by whole blood, plasma, urine, feces and expired air concentrations [ Time Frame: Day 1 - Day 6 ] [ Designated as safety issue: No ]AUCinf (Amount excreted in urine extrapolated until infinity), AUClast (Amount excreted in urine until last sample), Cmax (Maximum concentration), tmax (Time to attain maximum concentration), tlag (Absorption lag time) and t1/2 (Apparent terminal elimination half-life). Excretion rate and cumulative excretion of radioactivity in urine, feces and expired air.
- Pharmacokinetics of YM150 and metabolites assessed by plasma and urine concentrations [ Time Frame: Day 1 - Day 6 ] [ Designated as safety issue: No ]- AUCinf, AUClast, Cmax, tmax, tlag and t1/2. In urine - amount excreted in urine, CLR (Renal clearance) and % of dose excreted.
- Identification of the metabolic profile of YM150 in human plasma, urine and feces [ Time Frame: 0 - 2 hours Day 1 ] [ Designated as safety issue: No ]
- Monitoring of safety and tolerability through assessment of vital signs, Electrocardiogram (ECG), clinical safety laboratory and adverse events [ Time Frame: Day 1 - 14 ] [ Designated as safety issue: No ]
|Study Start Date:||February 2007|
|Study Completion Date:||March 2007|
|Primary Completion Date:||March 2007 (Final data collection date for primary outcome measure)|
|Experimental: Treatment arm 1||
14C-labeled YM150, oral solution
Other Name: darexaban
Healthy male subjects are admitted on Day 0. Subjects receive a single oral dose of 14C-labeled YM150 in the morning of Day 1 and remain in the unit for 7 days (6 nights). Blood, plasma, urine and feces samples are collected until 120 hrs after dosing for analysis of 14C-labeled radioactivity, YM150, YM-222714 and other metabolites. Expired air is collected as well for assessment of 14C-radioactivity.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01657981
|PRA International EDS NL|
|Zuidlaren, Netherlands, 9471 GP|
|Study Chair:||Clinical Study Manager||Astellas Pharma Europe B.V.|