NCT01657981

A Study to Find Out How YM150 is Absorbed Into and Eliminated From the Body in Healthy Male Subjects

An Open Label Study to Evaluate the Pharmacokinetics of YM150 After a Single Oral Dose of C14-labeled YM150 in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Astellas Pharma Europe B.V. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The study aims to observe how YM150 was absorbed, distributed and excreted after dosing with a radio labeled drinking solution.

Detailed description

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.

Conditions

• Pharmacokinetics
• Healthy Male Subjects

Interventions

Type	Name	Description
DRUG	YM150	14C-labeled YM150, oral solution

Timeline

• Start date: 2007-02-01
• Primary completion: 2007-03-01
• Completion: 2007-03-01
• First posted: 2012-08-06
• Last updated: 2013-06-26

Locations

1 site across 1 country: Netherlands