Study to Assess the Safety and Plasma Concentration of YM178 OCAS Tablet (Mirabegron) in Healthy Chinese Volunteers

Study Overview
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Brief Summary
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To evaluate the safety and plasma concentration change of YM178 after single- and repeated-administration as oral absorption controlled tablet in healthy Chinese subjects.

Official Title
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An Open-Label, Single and Multiple Dose Study to Assess the Safety and Pharmacokinetics of YM178 OCAS Tablet (Mirabegron) in Healthy Chinese Volunteers

Conditions
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Healthy Chinese Volunteers

Intervention / Treatment
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* Drug: YM178


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body Mass Index (BMI) between 19 and 24, the weight is no less than 50 kg. Good health status The female subject must be either post-menopausal or surgically sterile. All women of child bearing potential will be required to use adequate contraception, must not be lactating, and must not be breastfeeding. Exclusion Criteria: The subject who has a known or suspected hypersensitivity to test drug or any of the constituents of the formulation used. Drug abusers and alcoholics. The subject who has consumed alcohol within 36 hours before administration. The subject who is positive for hepatitis B surface antigen (HBs- Ag) or hepatitis C virus (HCV) antibody. The subject who is positive for human immunodeficiency virus (HIV). The subject who consumes more than 1L tea and coffee per day. Smokers. The subject who has donated or lost over 200 mL blood The subject who has participated in other clinical trials The subject who has taken other drugs that prototype and its main metabolites had not completely eliminated The subject who has taken drugs repeatedly that may affect the metabolism of the test drug Psychopath.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 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

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single dose group<br> | Drug: YM178<br>* oral<br>* Other names: Mirabegron;|
| Experimental: Multiple dose group<br> | Drug: YM178<br>* oral<br>* Other names: Mirabegron;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC of YM178 assessed by the plasma concentration changes |  | Up to 96 hours after administration | 
| Cmax of YM178 assessed by the plasma concentration changes |  | Up to 96 hours after administration | 
| t1/2 of YM178 assessed by the plasma concentration changes |  | Up to 96 hours after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessment of YM178 | Safety is to be assessed by the incidence of adverse events, vital signs, lab-tests and 12-lead ECGs | Up to 33 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PK, YM178, Mirabegron, OCAS, Chinese Healthy Volunteers, Safety