A Study to Assess the Systemic Pharmacokinetics, Metabolism and Excretion Routes of YM178 in Man, After Administration of Radio-labeled YM178
The study aims to assess the routes and the extent of metabolism and excretion of YM178 after a single dose of 14C-radiolabeled YM178 administered as a drinking solution in healthy male volunteers.
|Study Design:||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 YM178 After Single Oral Administration of 14C-labeled YM178 in Healthy Male Volunteers|
- The assessment of pharmacokinetic profile of radioactivity after single-dose administration of 14C-YM178, measured by whole blood and plasma concentration [ Time Frame: Baseline to Day 5 (optional (Day 6-8) [maximum of 19 assessments] ] [ Designated as safety issue: No ]Cmax, tmax, AUC0-last, AUC0-inf, t1/2 and the blood-to-plasma ratio (Ratio Cb/p)
- The excretion rate and cumulative excretion of radioactivity in urine, feces and expired air after single-dose administration of 14C-YM178 [ Time Frame: Baseline to Day 5 (optional (Day 6-8) [maximum of 10 assessments] ] [ Designated as safety issue: No ]
- The assessment of pharmacokinetic profile of parent YM178 after single-dose administration of 14C-YM178, measured plasma and urine concentration [ Time Frame: Baseline to Day 5 (optional (Day 6-8) [maximum of 19 assessments] ] [ Designated as safety issue: No ]plasma (Cmax, tmax, AUC0-last, AUC0-inf, t1/2 and Vz/F), urine (Ae0-24, Ae0-last, CLR and % dose excreted)
- Safety assessed through Adverse Events, vital signs, laboratory analyses and ECG (electrocardiogram) [ Time Frame: Through to Day 19 ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2003|
|Study Completion Date:||February 2003|
|Primary Completion Date:||February 2003 (Final data collection date for primary outcome measure)|
Experimental: 14C-labeled YM178
Single oral administration of 14C-labeled YM178
Drug: 14C-labeled YM178
oral solution (1.85 MBq)
Four subjects are studied in one group. Each subject stays in the clinic for 6 days, and receives a single oral dose of 14C-labeled YM178. Blood, plasma, urine, feces and expired air are collected for 96h after dosing.
If 14C-radioactivity quick counts show that radioactivity in urine or feces is above acceptable limits (ie. > 50 dpm/ml in urine; >75 dpm in 400 mg feces) on day 5, subjects are requested to stay in the clinic until the levels decrease. If, after 3 days, radioactivity is still > 50 dpm/ml in urine and/or >75 dpm in 400 mg feces, urine and/or feces is collected at home, until the amount of radioactivity decreases.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01651312
|Pharma Bio-Research Group B.V.|
|Zuidlaren, Netherlands, 9471 GP|
|Study Chair:||Clinical Study Manager||Astellas Pharma Europe B.V.|