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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01720212

Enrollment

Registered

2012-11-02

Start date

2012-05-31

Completion date

2012-08-31

Last updated

2012-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Chinese Volunteers

Keywords

YM178, Mirabegron, OCAS, Chinese Healthy Volunteers, PK, Safety

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.

Interventions

DRUGYM178

oral

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	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

Measure	Time frame	Description
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026