A Study in Healthy Young Men to Look at What Drives the Cardiovascular Effects After Dosing With Mirabegron.
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.
Pharmacodynamics of Mirabegron
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
|Official Title:||An Exploratory Study Into the Mechanism of Mirabegron-induced Cardiovascular Effects in Healthy Male Subjects.|
- Plasma renin activity [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
- Impedance cardiography [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
- Pharmacokinetic assessment of mirabegron by analysis of plasma samples [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
|Study Start Date:||July 2009|
|Study Completion Date:||November 2009|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
Other Name: YM178Drug: Bisoprolol
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01284868
|Paris, France, 75015|
|Study Director:||Use Central Contact||Astellas Pharma Europe B.V.|