NCT01651312

A Study to Assess the Systemic Pharmacokinetics, Metabolism and Excretion Routes of YM178 in Man, After Administration of Radio-labeled YM178

An Open-label Study to Evaluate the Pharmacokinetics of YM178 After Single Oral Administration of 14C-labeled YM178 in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Astellas Pharma Europe B.V. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Metabolic Processes

Interventions

Type	Name	Description
DRUG	14C-labeled YM178	oral solution (1.85 MBq)

Timeline

• Start date: 2003-01-01
• Primary completion: 2003-02-01
• Completion: 2003-02-01
• First posted: 2012-07-27
• Last updated: 2013-09-05

Locations

1 site across 1 country: Netherlands