NCT01478503

To Evaluate the Blood and Urine Concentration and the Safety and Tolerability of Increasing Repeated Doses of Mirabegron (YM178) OCAS in Healthy Young and Elderly Males and Healthy Young and Elderly Females

Double-blind, Randomized, Placebo-controlled, Dose-escalating, Exploratory Study to Investigate the Pharmacokinetics, Safety and Tolerability of Multiple Doses of YM178 OCAS-M in Healthy Young Male and Female Subjects and Healthy Elderly Male and Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The study aimed to compare age and gender differences for increasing doses of mirabegron when given to healthy young and elderly males and healthy young and elderly females.

Detailed description

Each subject will receive a single dose of mirabegron OCAS-M or placebo on Day 2, followed by multiple dosing (qd) for 10 days (Day 5-14). Young subjects will be divided into 4 groups and elderly subjects into 2 groups. Dosage will be different among groups.

Conditions

• Pharmacokinetics
• Healthy Subjects

Interventions

Type	Name	Description
DRUG	mirabegron OCAS	oral
DRUG	Placebo	oral

Timeline

• Start date: 2005-05-01
• Primary completion: 2005-10-01
• Completion: 2005-10-01
• First posted: 2011-11-23
• Last updated: 2013-07-02

Locations

2 sites across 1 country: Netherlands