A Study to Investigate the Effect of Mirabegron (YM178) on Subjects With Mild or Moderate Hepatic Impairment Compared to Healthy Subjects

Phase 1 Completed 32 enrolled Astellas Pharma Europe B.V.

Non-randomizedParallel-groupOpen-labelBasic science

Summary

The study aims to investigate and compare the effect of Mirabegron (YM178) on subjects with mild and moderate hepatic impairment compared to healthy subjects.

Timeline

Start: 2008-11
Primary completion: 2009-04
Completion: 2009-04

Publications

Background Dickinson J, Lewand M, Sawamoto T, Krauwinkel W, Schaddelee M, Keirns J, Kerbusch V, Moy S, Meijer J, Kowalski D, Morton R, Lasseter K, Riff D, Kupcova V, van Gelderen M. Effect of renal or hepatic impairment on the pharmacokinetics of mirabegron. Clin Drug Investig. 2013 Jan;33(1):11-23. doi: 10.1007/s40261-012-0031-3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mirabegron	Other / unclassified	—	Oral

Indications

No indication recorded.