<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01720212</url>
  </required_header>
  <id_info>
    <org_study_id>178-CL-091</org_study_id>
    <nct_id>NCT01720212</nct_id>
  </id_info>
  <brief_title>Study to Assess the Safety and Plasma Concentration of YM178 OCAS Tablet (Mirabegron) in Healthy Chinese Volunteers</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Astellas Pharma China, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Astellas Pharma Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the safety and plasma concentration change of YM178 after single- and&#xD;
      repeated-administration as oral absorption controlled tablet in healthy Chinese subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">August 2012</completion_date>
  <primary_completion_date type="Actual">August 2012</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>AUC of YM178 assessed by the plasma concentration changes</measure>
    <time_frame>Up to 96 hours after administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax of YM178 assessed by the plasma concentration changes</measure>
    <time_frame>Up to 96 hours after administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>t1/2 of YM178 assessed by the plasma concentration changes</measure>
    <time_frame>Up to 96 hours after administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety assessment of YM178</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Safety is to be assessed by the incidence of adverse events, vital signs, lab-tests and 12-lead ECGs</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Healthy Chinese Volunteers</condition>
  <arm_group>
    <arm_group_label>Single dose group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Multiple dose group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>YM178</intervention_name>
    <description>oral</description>
    <arm_group_label>Multiple dose group</arm_group_label>
    <arm_group_label>Single dose group</arm_group_label>
    <other_name>Mirabegron</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Body Mass Index (BMI) between 19 and 24, the weight is no less than 50 kg.&#xD;
&#xD;
          2. Good health status&#xD;
&#xD;
          3. The female subject must be either post-menopausal or surgically sterile. All women of&#xD;
             child bearing potential will be required to use adequate contraception, must not be&#xD;
             lactating, and must not be breastfeeding.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The subject who has a known or suspected hypersensitivity to test drug or any of the&#xD;
             constituents of the formulation used.&#xD;
&#xD;
          2. Drug abusers and alcoholics.&#xD;
&#xD;
          3. The subject who has consumed alcohol within 36 hours before administration.&#xD;
&#xD;
          4. The subject who is positive for hepatitis B surface antigen (HBs- Ag) or hepatitis C&#xD;
             virus (HCV) antibody.&#xD;
&#xD;
          5. The subject who is positive for human immunodeficiency virus (HIV).&#xD;
&#xD;
          6. The subject who consumes more than 1L tea and coffee per day.&#xD;
&#xD;
          7. Smokers.&#xD;
&#xD;
          8. The subject who has donated or lost over 200 mL blood&#xD;
&#xD;
          9. The subject who has participated in other clinical trials&#xD;
&#xD;
         10. The subject who has taken other drugs that prototype and its main metabolites had not&#xD;
             completely eliminated&#xD;
&#xD;
         11. The subject who has taken drugs repeatedly that may affect the metabolism of the test&#xD;
             drug&#xD;
&#xD;
         12. Psychopath.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Astellas Pharma Inc</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 31, 2012</study_first_submitted>
  <study_first_submitted_qc>October 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 2, 2012</study_first_posted>
  <last_update_submitted>October 31, 2012</last_update_submitted>
  <last_update_submitted_qc>October 31, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 2, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>YM178</keyword>
  <keyword>Mirabegron</keyword>
  <keyword>OCAS</keyword>
  <keyword>Chinese Healthy Volunteers</keyword>
  <keyword>PK</keyword>
  <keyword>Safety</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mirabegron</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01720212
org study id: 178-CL-091
nct id: NCT01720212
lead sponsor: 
has dmc: No
To evaluate the safety and plasma concentration change of YM178 after single- and
      repeated-administration as oral absorption controlled tablet in healthy Chinese subjects.
allocation: Non-Randomized
intervention model: Single Group Assignment
masking: None (Open Label)
measure: AUC of YM178 assessed by the plasma concentration changes
time frame: Up to 96 hours after administration
measure: Cmax of YM178 assessed by the plasma concentration changes
time frame: Up to 96 hours after administration
measure: t1/2 of YM178 assessed by the plasma concentration changes
time frame: Up to 96 hours after administration
measure: Safety assessment of YM178
time frame: Up to 33 days
description: Safety is to be assessed by the incidence of adverse events, vital signs, lab-tests and 12-lead ECGs
arm group label: Single dose group
arm group type: Experimental
arm group label: Multiple dose group
arm group type: Experimental
intervention type: Drug
intervention name: YM178
description: oral
arm group label: Multiple dose group
arm group label: Single dose group
other name: Mirabegron
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Medical Director
role: Study Director
affiliation: Astellas Pharma Inc
facility: 
country: China
responsible party type: Sponsor
mesh term: Mirabegron