<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/NCT02193217</url>
  </required_header>
  <id_info>
    <org_study_id>MT-1303-E12</org_study_id>
    <nct_id>NCT02193217</nct_id>
  </id_info>
  <brief_title>A Phase 1 Study to Explore the Cardiac Pharmacodynamics of MT-1303</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mitsubishi Tanabe Pharma Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mitsubishi Tanabe Pharma Corporation</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to explore the cardiac pharmacodynamics, safety and tolerability&#xD;
      of MT-1303 in healthy subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <primary_outcome>
    <measure>Mean hourly heart rate</measure>
    <time_frame>up to day 42</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plasma concentration of MT-1303 and its metabolite</measure>
    <time_frame>up to day 28</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">81</enrollment>
  <condition>Relapsing-remitting Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>MT-1303-Low</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MT-1303-Low dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MT-1303-High</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MT-1303-High dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fingolimod</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Fingolimod</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MT-1303-Low</intervention_name>
    <arm_group_label>MT-1303-Low</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MT-1303-High</intervention_name>
    <arm_group_label>MT-1303-High</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fingolimod</intervention_name>
    <arm_group_label>Fingolimod</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy and free from clinically significant illness or disease.&#xD;
&#xD;
          -  Male and female subjects of non-childbearing potential aged 18 to 55 years.&#xD;
&#xD;
          -  Normal or non-clinically significant 12-lead ECG.&#xD;
&#xD;
          -  Holter recording with no clinically significant abnormalities.&#xD;
&#xD;
          -  Systolic blood pressure: 90 to 140 mmHg, diastolic blood pressure: 50 to 90 mmHg&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A History of severe adverse reaction or allergy to any medical product.&#xD;
&#xD;
          -  Clinically significant endocrine, thyroid, hepatic, respiratory, gastrointestinal,&#xD;
             renal, cardiovascular disease, eye disorder or history of psychiatric/psychotic&#xD;
             disorder.&#xD;
&#xD;
          -  A history of tuberculosis.&#xD;
&#xD;
          -  Have a positive HBsAg, HBcAb, HCVAb or HIV-1 and HIV-2 test.&#xD;
&#xD;
          -  Previously having received MT-1303, fingolimod, or any other sphingosine-1-phosphate&#xD;
             receptor modulators.&#xD;
&#xD;
          -  Clinical relevant abnormal medical history, or physical findings or laboratory values.&#xD;
&#xD;
          -  Clinically significant 12-lead ECG abnormalities.&#xD;
&#xD;
          -  Clinical relevant abnormal findings in echocardiograph.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter Sowood, M.D</last_name>
    <role>Study Director</role>
    <affiliation>Mitsubishi Tanabe Pharma Europe Ltd.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Investigational site</name>
      <address>
        <city>Leeds</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2015</verification_date>
  <study_first_submitted>July 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <last_update_submitted>February 19, 2015</last_update_submitted>
  <last_update_submitted_qc>February 19, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 20, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Multiple Sclerosis, Relapsing-Remitting</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fingolimod Hydrochloride</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/NCT02193217
org study id: MT-1303-E12
nct id: NCT02193217
lead sponsor: 
The purpose of this study is to explore the cardiac pharmacodynamics, safety and tolerability
      of MT-1303 in healthy subjects.
measure: Mean hourly heart rate
time frame: up to day 42
measure: Plasma concentration of MT-1303 and its metabolite
time frame: up to day 28
arm group label: MT-1303-Low
arm group type: Experimental
description: MT-1303-Low dose
arm group label: MT-1303-High
arm group type: Experimental
description: MT-1303-High dose
arm group label: Fingolimod
arm group type: Active Comparator
description: Fingolimod
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo
intervention type: Drug
intervention name: MT-1303-Low
arm group label: MT-1303-Low
intervention type: Drug
intervention name: MT-1303-High
arm group label: MT-1303-High
intervention type: Drug
intervention name: Fingolimod
arm group label: Fingolimod
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Peter Sowood, M.D
role: Study Director
affiliation: Mitsubishi Tanabe Pharma Europe Ltd.
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Multiple Sclerosis
mesh term: Multiple Sclerosis, Relapsing-Remitting
mesh term: Fingolimod Hydrochloride