Healthy Subjects Clinical Trial
Official title:
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
The objective of this study is to evaluate the effect of repeat oral dosing of mirabegron on ECG (electrocardiogram) measurements.
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. ;
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
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