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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:
ClinicalTrials.gov Identifier:
NCT01720212
First Posted: November 2, 2012
Last Update Posted: November 2, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma China, Inc. )
  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
Intervention Model: Single Group Assignment
Masking: None (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:


Further study details as provided by Astellas Pharma Inc ( Astellas Pharma China, Inc. ):

Primary Outcome Measures:
  • AUC of YM178 assessed by the plasma concentration changes [ Time Frame: Up to 96 hours after administration ]
  • Cmax of YM178 assessed by the plasma concentration changes [ Time Frame: Up to 96 hours after administration ]
  • t1/2 of YM178 assessed by the plasma concentration changes [ Time Frame: Up to 96 hours after administration ]

Secondary Outcome Measures:
  • Safety assessment of YM178 [ Time Frame: Up to 33 days ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01720212


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

Responsible Party: Astellas Pharma China, Inc.
ClinicalTrials.gov Identifier: NCT01720212     History of Changes
Other Study ID Numbers: 178-CL-091
First Submitted: October 31, 2012
First Posted: November 2, 2012
Last Update Posted: November 2, 2012
Last Verified: October 2012

Keywords provided by Astellas Pharma Inc ( Astellas Pharma China, Inc. ):
YM178
Mirabegron
OCAS
Chinese Healthy Volunteers
PK
Safety

Additional relevant MeSH terms:
Mirabegron
Adrenergic beta-3 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents