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

Healthy Chinese Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01720212
• Other study ID #: 178-CL-091
• Status: Completed
• Phase: Phase 1
• First received: October 31, 2012
• Last updated: October 31, 2012
• Start date: May 2012
• Est. completion date: August 2012

Study information

• Verified date: October 2012
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Chinese Volunteers

Intervention

Drug:
• YM178
oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma China, Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC of YM178 assessed by the plasma concentration changes		Up to 96 hours after administration	No
Primary	Cmax of YM178 assessed by the plasma concentration changes		Up to 96 hours after administration	No
Primary	t1/2 of YM178 assessed by the plasma concentration changes		Up to 96 hours after administration	No
Secondary	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	No