drugset

drugset / Trial / NCT01199523

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

NCT01199523 ↗

Phase 1 Completed 352 enrolled Astellas Pharma Inc

RandomizedCrossoverTriple-blind

Summary

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

Timeline

Start: 2010-05
Primary completion: 2010-11
Completion: 2010-11

Publications

Background Malik M, van Gelderen EM, Lee JH, Kowalski DL, Yen M, Goldwater R, Mujais SK, Schaddelee MP, de Koning P, Kaibara A, Moy SS, Keirns JJ. Proarrhythmic safety of repeat doses of mirabegron in healthy subjects: a randomized, double-blind, placebo-, and active-controlled thorough QT study. Clin Pharmacol Ther. 2012 Dec;92(6):696-706. doi: 10.1038/clpt.2012.181. Epub 2012 Nov 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mirabegron	Other / unclassified	—	Oral
Comparator	Moxifloxacin	Small molecule	—	Oral

Indications

No indication recorded.