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

NCT ID: NCT01720212

Last Updated: 2012-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2012-08-31

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.

Detailed Description

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Conditions

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Healthy Chinese Volunteers

Keywords

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YM178 Mirabegron OCAS Chinese Healthy Volunteers PK Safety

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Single dose group

Group Type EXPERIMENTAL

YM178

Intervention Type DRUG

oral

Multiple dose group

Group Type EXPERIMENTAL

YM178

Intervention Type DRUG

oral

Interventions

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YM178

oral

Intervention Type DRUG

Other Intervention Names

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Mirabegron

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Astellas Pharma China, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Astellas Pharma Inc

Locations

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Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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178-CL-091

Identifier Type: -

Identifier Source: org_study_id