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

Phase 1

Completed

• Conditions: Healthy Chinese Volunteers
• Interventions: Drug: YM178

• Registration Number: NCT01720212
• Lead Sponsor: Astellas Pharma China, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2012-10
• Study First Submitted: 2012-10-31
• Study First Submitted QC: 2012-10-31
• Last Update Submitted: 2012-10-31
• Study First Posted: 2012-11-02
• Last Update Posted: 2012-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Body Mass Index (BMI) between 19 and 24, the weight is no less than 50 kg.
2. Good health status
3. 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

1. The subject who has a known or suspected hypersensitivity to test drug or any of the constituents of the formulation used.
2. Drug abusers and alcoholics.
3. The subject who has consumed alcohol within 36 hours before administration.
4. The subject who is positive for hepatitis B surface antigen (HBs- Ag) or hepatitis C virus (HCV) antibody.
5. The subject who is positive for human immunodeficiency virus (HIV).
6. The subject who consumes more than 1L tea and coffee per day.
7. Smokers.
8. The subject who has donated or lost over 200 mL blood
9. The subject who has participated in other clinical trials
10. The subject who has taken other drugs that prototype and its main metabolites had not completely eliminated
11. The subject who has taken drugs repeatedly that may affect the metabolism of the test drug
12. Psychopath.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single dose group	YM178	-
Multiple dose group	YM178	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Safety assessment of YM178	Up to 33 days	Safety is to be assessed by the incidence of adverse events, vital signs, lab-tests and 12-lead ECGs