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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma China, Inc. )
ClinicalTrials.gov Identifier:
NCT01720212
First received: October 31, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
  Purpose

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


Condition Intervention Phase
Healthy Chinese Volunteers
 Drug: YM178
 Phase 1

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

Resource links provided by NLM:

Drug Information available for: Mirabegron
U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • AUC of YM178 assessed by the plasma concentration changes [ Time Frame: Up to 96 hours after administration ] [ Designated as safety issue: No ]
  • Cmax of YM178 assessed by the plasma concentration changes [ Time Frame: Up to 96 hours after administration ] [ Designated as safety issue: No ]
  • t1/2 of YM178 assessed by the plasma concentration changes [ Time Frame: Up to 96 hours after administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety assessment of YM178 [ Time Frame: Up to 33 days ] [ Designated as safety issue: No ]
    Safety is to be assessed by the incidence of adverse events, vital signs, lab-tests and 12-lead ECGs


Enrollment: 24
Study Start Date: May 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single dose group Drug: YM178
oral
Other Name: Mirabegron
Experimental: Multiple dose group Drug: YM178
oral
Other Name: Mirabegron

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01720212

Locations
China
Shanghai, China
Sponsors and Collaborators
Astellas Pharma China, Inc.
Investigators
Study Director: Medical Director Astellas Pharma Inc
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc ( Astellas Pharma China, Inc. )
ClinicalTrials.gov Identifier: NCT01720212     History of Changes
Other Study ID Numbers: 178-CL-091
Study First Received: October 31, 2012
Last Updated: October 31, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
YM178
Mirabegron
OCAS
 Chinese Healthy Volunteers
PK
Safety

ClinicalTrials.gov processed this record on June 18, 2013