A Study to Evaluate Absorption, Distribution and Elimination of Mirabegron After Oral Administration to Non-elderly Healthy Chinese Subjects

Study Overview
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Brief Summary
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The purpose of this study is to evaluate safety and absorption, distribution and elimination of mirabegron after oral administration to Chinese subjects.

Detailed Description
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This study is an open-label study. The subjects will receive single administration of mirabegron in a fasted condition. After the non-dosing period, subjects will receive mirabegron for 8 days.

Official Title
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A Study to Evaluate Pharmacokinetics of Mirabegron After Single and Multiple Oral Administration to Healthy Non-elderly Male and Female Chinese Subjects

Conditions
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Healthy Subjects, Plasma Concentration of Mirabegron

Intervention / Treatment
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* Drug: YM178 (mirabegron)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body weight: (male) over 50.0kg and less than 80.0kg (female) over 40.0kg and less than 70.0kg Body Mass Index: over 17.6 and less than 26.4 kg/m Chinese subjects Healthy judged by investigator or sub-investigator Exclusion Criteria: Received any investigational drugs within 120 days before the screening assessment Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before the screening assessment Received medication within 7 days before hospital admission A deviation from the assessment criteria of physical examinations or laboratory tests at screening or upon admission History of drug allergies With renal, hepatic, gastrointestinal, heart, cerebrovascular or respiratory diseases Received mirabegron beforehand Glaucoma patient

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mirabegron group<br> | Drug: YM178 (mirabegron)<br>* oral<br>* Other names: mirabegron;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic (PK) profile for ASP015K (in plasma): Cmax, AUClast, AUCinf and AUC0-24h | Maximum concentration (Cmax), Area under the curve (AUC) from time 0 extrapolated to infinity (AUCinf), AUC from time of dosing to last quantifiable concentration (AUClast ), and AUC from time 0 to 24hr (AUC0-24h) | Day 1-5 and Day 10, 11, 14-21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessed by the incidence of adverse events, vital signs, lab-test and 12-lead ECGs |  | Through day 25 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics, Mirabegron, Phase 1, YM178