NCT01284868

A Study in Healthy Young Men to Look at What Drives the Cardiovascular Effects After Dosing With Mirabegron.

An Exploratory Study Into the Mechanism of Mirabegron-induced Cardiovascular Effects in Healthy Male Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: Male
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

To explore what is driving heart-rate increases after dosing with mirabegron. Subjects will be given a beta-blocker at the same time as mirabegron.

Detailed description

Impedance cardiography parameters will be assessed and compared when mirabegron (or placebo), is taken in combination with a selective beta-blocker, a non-selective beta-blocker or placebo.

Conditions

• Healthy Volunteers
• Pharmacodynamics of Mirabegron

Interventions

Type	Name	Description
DRUG	mirabegron	oral
DRUG	Bisoprolol	oral
DRUG	propranolol	oral
DRUG	placebo	oral

Timeline

• Start date: 2009-07-01
• Primary completion: 2009-11-01
• Completion: 2009-11-01
• First posted: 2011-01-27
• Last updated: 2013-07-03

Locations

1 site across 1 country: France