A Phase 1 interventional study of mirabegron OCAS and Placebo in Pharmacokinetics and Healthy Subjects, sponsored by Astellas Pharma Inc. Completed at 2 sites in Netherlands. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-07-02.
Sponsored by Astellas Pharma Inc · Phase 1 and Interventional
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.
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.
Astellas Pharma Inc is the lead sponsor of 512 studies on the registry; 4 are open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 19 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
mirabegron
Drug: mirabegron OCAS
matching placebo
Drug: Placebo
oral
Also known as: YM178 OCAS
oral
Pharmacokinetics of mirabegron assessed by plasma concentration
Time frame: Pre-dose until 72 hours after dosing
Monitoring of safety and tolerability through assessment of vital signs, Electrocardiogram (ECG), clinical safety laboratory and adverse events
Time frame: Baseline until 72 hours after dosing
This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.
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Astellas Pharma Inc