NCT01199523

A Study to Evaluate the Effect of Oral Mirabegron on the Heart in Healthy Males and Females

A Phase 1, Randomized, Double-Blind, Placebo and Active Controlled, Parallel Crossover Study to Evaluate the Effect of Repeat Oral Doses of Mirabegron on Cardiac Repolarization in Healthy Male and Female Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 352 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to evaluate the effect of repeat oral dosing of mirabegron on ECG (electrocardiogram) measurements.

Detailed description

Each subject will be randomized and participate in two 10-day treatment periods during which once daily dosing of mirabegron and mirabegron/moxifloxacin placebo or moxifloxacin and moxifloxacin/mirabegron placebo will occur followed by a 1-day post-treatment period. Each treatment period will be separated by a washout period of at least 12 days from the last dose of study drug on Day 10 of Period 1 to Day -4 of Period 2.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Placebo	oral
DRUG	mirabegron	oral
DRUG	moxifloxacin	oral

Timeline

• Start date: 2010-05-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2010-09-13
• Last updated: 2013-07-03

Locations

2 sites across 1 country: United States