<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/NCT03809039</url>
  </required_header>
  <id_info>
    <org_study_id>MT-6345-E01</org_study_id>
    <secondary_id>2018-002478-39</secondary_id>
    <nct_id>NCT03809039</nct_id>
  </id_info>
  <brief_title>A Study to Investigate the Safety, Tolerability and Pharmacokinetics of MT-6345 in Healthy Subjects</brief_title>
  <official_title>A Randomised, Double-Blind, Placebo-Controlled Phase I Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of MT-6345 in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mitsubishi Tanabe Pharma America Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mitsubishi Tanabe Pharma America Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to Investigate the Safety, Tolerability and Pharmacokinetics of&#xD;
      MT-6345 in Healthy Subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Preclinical finding&#xD;
  </why_stopped>
  <start_date type="Actual">January 15, 2019</start_date>
  <completion_date type="Actual">July 1, 2020</completion_date>
  <primary_completion_date type="Actual">July 1, 2019</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Mild, Moderate and Severe Adverse Events</measure>
    <time_frame>Up to 6 weeks</time_frame>
    <description>The criteria of Mild, Moderate and Severe are as follows:&#xD;
Mild: The event is transient and easily tolerated by the subject.&#xD;
Moderate: The event causes discomfort and interferes with the subject's general condition.&#xD;
Severe: The event causes considerable interference with the subject's general condition and may be incapacitating.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum Plasma Concentration (Cmax) of MT-6345</measure>
    <time_frame>Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hours. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours.</time_frame>
    <description>Cmax was measured for MT-6345 for the PK analysis set (PKPOP) subjects in Part 1 and Part 2, and on Day 1 in Part 3.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Maximum Plasma Concentration (Tmax) of MT-6345</measure>
    <time_frame>Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hours. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours.</time_frame>
    <description>Tmax was measured for MT-6345 for the PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Terminal Elimination Half Life (t½) of MT-6345</measure>
    <time_frame>Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hours. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours.</time_frame>
    <description>t1/2 was measured for MT-6345 for the PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Plasma Concentration Time Curve From Time Zero to 24 Hours (AUC0-24h) of MT-6345</measure>
    <time_frame>Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hours. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours.</time_frame>
    <description>AUC(0-24h) was computed for MT-6345 for the PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Plasma Concentration Time Curve From Time Zero to the Last Measurable Concentration (AUC0-last) of MT-6345</measure>
    <time_frame>Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hours. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours.</time_frame>
    <description>AUC(0-last) was computed for MT-6345 for the PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-∞) of MT-6345</measure>
    <time_frame>Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hour. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours.</time_frame>
    <description>AUC(0-∞) was calculated for the PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal Elimination Rate Constant (Kel) of MT-6345</measure>
    <time_frame>Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hours. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours.</time_frame>
    <description>Kel was estimated for the PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Residence Time (MRT) of MT-6345</measure>
    <time_frame>Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hours. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours.</time_frame>
    <description>MRT was calculated for the PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Oral Clearance (CL/F) of MT-6345</measure>
    <time_frame>Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hours. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours.</time_frame>
    <description>CL/F was measured for MT-6345 in the PKPOP subjects of Part 1 and Part 2, and on Day 1 in Part 3.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Plasma Concentration Time Curve Over the Dosing Interval (AUC0-t) of MT-6345.</measure>
    <time_frame>up to 2 weeks after dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Volume of Distribution at Steady State (Vss/F) of MT-6345</measure>
    <time_frame>Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hours. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours.</time_frame>
    <description>Vss/F was measured for MT-6345 in the PKPOP subjects of Part 1 and Part 2, and on Day 1 in Part 3.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Linearity Factor (LF) of MT-6345</measure>
    <time_frame>up to 2 weeks after dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accumulation Ratio (RA) of MT-6345</measure>
    <time_frame>up to 2 weeks after dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urinary Excreted Amount of Test Compound (Ae) of MT-6345</measure>
    <time_frame>Day 1 (0 hours to 24 hours) and Day 10 (0 hours to 24 hours)</time_frame>
    <description>Ae was measured for MT-6345 for the PKPOP subjects in Part 3.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urinary Excreted Amount of Test Compound Expressed as a Percentage of the Dose Administered (Ae%) of MT-6345</measure>
    <time_frame>Day 1 (pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 16 hours) and Day 2 to Day 10 (pre-dose on each day)</time_frame>
    <description>Ae% was measured for MT-6345 for the PKPOP subjects in Part 3.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal Clearance (CLR) of MT-6345</measure>
    <time_frame>Day 1 (0 hours to 24 hours) and Day 10 (0 hours to 24 hours)</time_frame>
    <description>CLR was measured for MT-6345 for the PKPOP subjects in Part 3. For Day 10, CLR was not calculated because AUC(0-24h) on the last day of dosing was not calculated.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Single Ascending Dose: MT-6345 &amp; Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Multiple Ascending Dose: MT-6345 &amp; Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MT-6345</intervention_name>
    <description>MT-6345</description>
    <arm_group_label>Multiple Ascending Dose: MT-6345 &amp; Placebo</arm_group_label>
    <arm_group_label>Single Ascending Dose: MT-6345 &amp; Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MT-6345 Placebo</intervention_name>
    <description>MT-6345 Placebo</description>
    <arm_group_label>Multiple Ascending Dose: MT-6345 &amp; Placebo</arm_group_label>
    <arm_group_label>Single Ascending Dose: MT-6345 &amp; Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Additional screening criteria check may apply for qualification:&#xD;
&#xD;
          -  Able to provide written informed consent to participate in this study after reading&#xD;
             the participant information sheet and Informed Consent Form (ICF), and after having&#xD;
             the opportunity to discuss the study with the Investigator or designee.&#xD;
&#xD;
          -  Healthy and free from clinically significant illness or disease as determined by&#xD;
             medical history, physical examination, laboratory and other tests at Screening and Day&#xD;
             -1.&#xD;
&#xD;
          -  A body weight of ≥60 kg for males and ≥50 kg for females and a body mass index (BMI)&#xD;
             (Quetelet index) ranging from 18 to 30.0 kg/m2 inclusive at Screening and Day -1.&#xD;
&#xD;
          -  In the Investigator's opinion, subject is able to understand the nature of the study&#xD;
             and any risks involved in participation, and willing to cooperate and comply with the&#xD;
             Protocol restrictions and requirements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Additional screening criteria check may apply for qualification:&#xD;
&#xD;
          -  Subjects with clinically significant (in the opinion of the Investigator) endocrine,&#xD;
             thyroid, hepatic, respiratory, gastrointestinal, neurological, renal, cardiovascular&#xD;
             disease, or history (within the last 5 years) of any significant psychiatric/psychotic&#xD;
             illness disorder (including anxiety, depression and reactive depression).&#xD;
&#xD;
          -  Female subjects who are pregnant (positive pregnancy test at Screening or Day -1) or&#xD;
             lactating.&#xD;
&#xD;
          -  Having previously received MT-6345 as part of this study.&#xD;
&#xD;
          -  Clinically relevant abnormal medical history, physical findings or laboratory values&#xD;
             at Screening or Day -1 that could interfere with the objectives of the study or the&#xD;
             safety of the subject, as judged by the Investigator.&#xD;
&#xD;
          -  Subjects who test positive for hepatitis B surface antigen, hepatitis B core antibody,&#xD;
             hepatitis C antibody, human immunodeficiency virus (HIV)-1 or HIV-2 antibodies at&#xD;
             Screening.&#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>Head of Medical Science,</last_name>
    <role>Study Director</role>
    <affiliation>Mitsubishi Tanabe Pharma America Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Investigational center</name>
      <address>
        <city>City Name</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>January 16, 2019</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <results_first_submitted>June 2, 2021</results_first_submitted>
  <results_first_submitted_qc>August 25, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">September 21, 2021</results_first_posted>
  <last_update_submitted>May 12, 2023</last_update_submitted>
  <last_update_submitted_qc>May 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 12, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/39/NCT03809039/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 1, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/39/NCT03809039/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>6 subjects of Part 1 were selected for Part 2.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Part 1 and Part 2 Placebo</title>
          <description>Single dose</description>
        </group>
        <group group_id="P2">
          <title>Part 1: MT-6345 1 mg</title>
          <description>Single dose</description>
        </group>
        <group group_id="P3">
          <title>Part 1: MT-6345 5 mg</title>
          <description>Single dose</description>
        </group>
        <group group_id="P4">
          <title>Part 1 and Part 2: MT-6345 20 mg</title>
          <description>Single dose</description>
        </group>
        <group group_id="P5">
          <title>Part 1: MT-6345 60 mg</title>
          <description>Single dose</description>
        </group>
        <group group_id="P6">
          <title>Part 1: MT-6345 120 mg</title>
          <description>Single dose</description>
        </group>
        <group group_id="P7">
          <title>Part 1: MT-6345 240 mg</title>
          <description>Single dose</description>
        </group>
        <group group_id="P8">
          <title>Part 3: Placebo</title>
          <description>Multiple dose</description>
        </group>
        <group group_id="P9">
          <title>Part 3: MT-6345 60 mg</title>
          <description>Multiple dose</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Part 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="11">11 subjects (2 subjects in each of Part 1 MT-6345 1 mg, 5 mg, 20 mg, 60 mg, 240 mg, and 1 subject in Part 1 MT-6345 120 mg) received a matching placebo per their respective dose. The subjects are unique subjects, and were not counted more than once across any arms except for Part 2 Placebo.</participants>
                <participants group_id="P2" count="6">The subjects are unique subjects, and were not counted more than once across any arms.</participants>
                <participants group_id="P3" count="6">The subjects are unique subjects, and were not counted more than once across any arms.</participants>
                <participants group_id="P4" count="6">The subjects are unique subjects, and were not counted more than once across any arms except for Part 2 MT-6345 20mg.</participants>
                <participants group_id="P5" count="6">The subjects are unique subjects, and were not counted more than once across any arms.</participants>
                <participants group_id="P6" count="4">The subjects are unique subjects, and were not counted more than once across any arms.</participants>
                <participants group_id="P7" count="5">The subjects are unique subjects, and were not counted more than once across any arms.</participants>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="5"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="4"/>
                <participants group_id="P7" count="5"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Part 2</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1">2 subjects who received a matching placebo per Part 1 MT-6345 20mg were selected to return for Part 2. Out of 2 subjects, only 1 subject received the placebo, and another subject withdrew the consent after Part 1. Therefore, this 1 subject is not a unique subject and was not counted again in the total number of exposed subjects.</participants>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="5">6 subjects in Part 1 MT-6345 20mg were selected to return for Part 2. Out of 6 subjects, only 5 subjects received MT-6345, and 1 subject withdrew the consent after Part 1. Therefore, these 5 subjects are not a unique subject and were not counted again in the total number of exposed subjects.</participants>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="5"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Part 3</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="2">The subjects are unique subjects, and were not counted more than once across any arms.</participants>
                <participants group_id="P9" count="6">The subjects are unique subjects, and were not counted more than once across any arms.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="2"/>
                <participants group_id="P9" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawn by study termination</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="2"/>
                <participants group_id="P9" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The analysis population is the subjects of Part 1 and Part 3 since the subjects of part 2 were selected from part 1.</population>
      <group_list>
        <group group_id="B1">
          <title>Part 1 Placebo</title>
          <description>Single dose</description>
        </group>
        <group group_id="B2">
          <title>Part 1: MT-6345 1 mg</title>
          <description>Single dose</description>
        </group>
        <group group_id="B3">
          <title>Part 1: MT-6345 5 mg</title>
          <description>Single dose</description>
        </group>
        <group group_id="B4">
          <title>Part 1: MT-6345 20 mg</title>
          <description>Single dose</description>
        </group>
        <group group_id="B5">
          <title>Part 1: MT-6345 60 mg</title>
          <description>Single dose</description>
        </group>
        <group group_id="B6">
          <title>Part 1: MT-6345 120 mg</title>
          <description>Single dose</description>
        </group>
        <group group_id="B7">
          <title>Part 1: MT-6345 240 mg</title>
          <description>Single dose</description>
        </group>
        <group group_id="B8">
          <title>Part 3 Placebo</title>
          <description>Multiple dose</description>
        </group>
        <group group_id="B9">
          <title>Part 3: MT-6345 60 mg</title>
          <description>Multiple dose</description>
        </group>
        <group group_id="B10">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="11"/>
            <count group_id="B2" value="6"/>
            <count group_id="B3" value="6"/>
            <count group_id="B4" value="6"/>
            <count group_id="B5" value="6"/>
            <count group_id="B6" value="4"/>
            <count group_id="B7" value="5"/>
            <count group_id="B8" value="2"/>
            <count group_id="B9" value="6"/>
            <count group_id="B10" value="52"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>18-64 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="4"/>
                    <measurement group_id="B7" value="5"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="6"/>
                    <measurement group_id="B10" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="4"/>
                    <measurement group_id="B7" value="5"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="6"/>
                    <measurement group_id="B10" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="4"/>
                    <measurement group_id="B7" value="5"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="6"/>
                    <measurement group_id="B10" value="52"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="4"/>
                    <measurement group_id="B7" value="5"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="6"/>
                    <measurement group_id="B10" value="52"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Mild, Moderate and Severe Adverse Events</title>
        <description>The criteria of Mild, Moderate and Severe are as follows:&#xD;
Mild: The event is transient and easily tolerated by the subject.&#xD;
Moderate: The event causes discomfort and interferes with the subject's general condition.&#xD;
Severe: The event causes considerable interference with the subject's general condition and may be incapacitating.</description>
        <time_frame>Up to 6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Part 1 Placebo</title>
            <description>Single dose</description>
          </group>
          <group group_id="O2">
            <title>Part 1: MT-6345 1 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O3">
            <title>Part 1: MT-6345 5 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O4">
            <title>Part 1: MT-6345 20 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O5">
            <title>Part 1: MT-6345 60 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O6">
            <title>Part 1: MT-6345 120 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O7">
            <title>Part 1: MT-6345 240 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O8">
            <title>Part 2: Placebo</title>
            <description>Single dose</description>
          </group>
          <group group_id="O9">
            <title>Part 2: MT-6345 20 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O10">
            <title>Part 3: Placebo</title>
            <description>Multiple dose</description>
          </group>
          <group group_id="O11">
            <title>Part 3: MT-6345 60 mg</title>
            <description>Multiple dose</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Mild, Moderate and Severe Adverse Events</title>
          <description>The criteria of Mild, Moderate and Severe are as follows:&#xD;
Mild: The event is transient and easily tolerated by the subject.&#xD;
Moderate: The event causes discomfort and interferes with the subject's general condition.&#xD;
Severe: The event causes considerable interference with the subject's general condition and may be incapacitating.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="4"/>
                <count group_id="O7" value="5"/>
                <count group_id="O8" value="1"/>
                <count group_id="O9" value="5"/>
                <count group_id="O10" value="2"/>
                <count group_id="O11" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="2"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="2"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Plasma Concentration (Cmax) of MT-6345</title>
        <description>Cmax was measured for MT-6345 for the PK analysis set (PKPOP) subjects in Part 1 and Part 2, and on Day 1 in Part 3.</description>
        <time_frame>Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hours. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours.</time_frame>
        <population>PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: MT-6345 1 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O2">
            <title>Part 1: MT-6345 5 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O3">
            <title>Part 1: MT-6345 20 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O4">
            <title>Part 1: MT-6345 60 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O5">
            <title>Part 1: MT-6345 120 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O6">
            <title>Part 1: MT-6345 240 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O7">
            <title>Part 2: MT-6345 20 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O8">
            <title>Part 3: MT-6345 60 mg</title>
            <description>Multiple dose</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Plasma Concentration (Cmax) of MT-6345</title>
          <description>Cmax was measured for MT-6345 for the PK analysis set (PKPOP) subjects in Part 1 and Part 2, and on Day 1 in Part 3.</description>
          <population>PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="4"/>
                <count group_id="O6" value="5"/>
                <count group_id="O7" value="5"/>
                <count group_id="O8" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.219" spread="1.414"/>
                    <measurement group_id="O2" value="37.37" spread="9.471"/>
                    <measurement group_id="O3" value="153.3" spread="38.85"/>
                    <measurement group_id="O4" value="386.2" spread="65.23"/>
                    <measurement group_id="O5" value="780.9" spread="118.5"/>
                    <measurement group_id="O6" value="1522" spread="301.7"/>
                    <measurement group_id="O7" value="141.0" spread="42.39"/>
                    <measurement group_id="O8" value="523.8" spread="200.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Maximum Plasma Concentration (Tmax) of MT-6345</title>
        <description>Tmax was measured for MT-6345 for the PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3.</description>
        <time_frame>Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hours. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours.</time_frame>
        <population>PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: MT-6345 1 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O2">
            <title>Part 1: MT-6345 5 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O3">
            <title>Part 1: MT-6345 20 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O4">
            <title>Part 1: MT-6345 60 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O5">
            <title>Part 1: MT-6345 120 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O6">
            <title>Part 1: MT-6345 240 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O7">
            <title>Part 2: MT-6345 20 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O8">
            <title>Part 3: MT-6345 60 mg</title>
            <description>Multiple dose</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Maximum Plasma Concentration (Tmax) of MT-6345</title>
          <description>Tmax was measured for MT-6345 for the PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3.</description>
          <population>PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3.</population>
          <units>hour</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="4"/>
                <count group_id="O6" value="5"/>
                <count group_id="O7" value="5"/>
                <count group_id="O8" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.75" lower_limit="0.50" upper_limit="1.00"/>
                    <measurement group_id="O2" value="1.01" lower_limit="1.00" upper_limit="1.52"/>
                    <measurement group_id="O3" value="1.00" lower_limit="0.50" upper_limit="2.00"/>
                    <measurement group_id="O4" value="1.50" lower_limit="0.50" upper_limit="2.01"/>
                    <measurement group_id="O5" value="1.50" lower_limit="0.50" upper_limit="1.50"/>
                    <measurement group_id="O6" value="1.50" lower_limit="1.00" upper_limit="1.50"/>
                    <measurement group_id="O7" value="2.00" lower_limit="0.50" upper_limit="5.00"/>
                    <measurement group_id="O8" value="1.25" lower_limit="0.50" upper_limit="2.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Plasma Terminal Elimination Half Life (t½) of MT-6345</title>
        <description>t1/2 was measured for MT-6345 for the PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3.</description>
        <time_frame>Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hours. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours.</time_frame>
        <population>PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: MT-6345 1 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O2">
            <title>Part 1: MT-6345 5 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O3">
            <title>Part 1: MT-6345 20 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O4">
            <title>Part 1: MT-6345 60 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O5">
            <title>Part 1: MT-6345 120 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O6">
            <title>Part 1: MT-6345 240 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O7">
            <title>Part 2: MT-6345 20 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O8">
            <title>Part 3: MT-6345 60 mg</title>
            <description>Multiple dose</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Terminal Elimination Half Life (t½) of MT-6345</title>
          <description>t1/2 was measured for MT-6345 for the PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3.</description>
          <population>PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3.</population>
          <units>hour</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="4"/>
                <count group_id="O6" value="5"/>
                <count group_id="O7" value="5"/>
                <count group_id="O8" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.89" spread="12.54"/>
                    <measurement group_id="O2" value="31.83" spread="7.16"/>
                    <measurement group_id="O3" value="34.99" spread="8.69"/>
                    <measurement group_id="O4" value="44.38" spread="10.76"/>
                    <measurement group_id="O5" value="46.03" spread="22.76"/>
                    <measurement group_id="O6" value="47.43" spread="31.58"/>
                    <measurement group_id="O7" value="39.46" spread="8.96"/>
                    <measurement group_id="O8" value="31.09" spread="8.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Plasma Concentration Time Curve From Time Zero to 24 Hours (AUC0-24h) of MT-6345</title>
        <description>AUC(0-24h) was computed for MT-6345 for the PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3.</description>
        <time_frame>Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hours. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours.</time_frame>
        <population>PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: MT-6345 1 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O2">
            <title>Part 1: MT-6345 5 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O3">
            <title>Part 1: MT-6345 20 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O4">
            <title>Part 1: MT-6345 60 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O5">
            <title>Part 1: MT-6345 120 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O6">
            <title>Part 1: MT-6345 240 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O7">
            <title>Part 2: MT-6345 20 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O8">
            <title>Part 3: MT-6345 60 mg</title>
            <description>Multiple dose</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Plasma Concentration Time Curve From Time Zero to 24 Hours (AUC0-24h) of MT-6345</title>
          <description>AUC(0-24h) was computed for MT-6345 for the PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3.</description>
          <population>PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3.</population>
          <units>ng.h/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="4"/>
                <count group_id="O6" value="5"/>
                <count group_id="O7" value="5"/>
                <count group_id="O8" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.6" spread="12.6"/>
                    <measurement group_id="O2" value="342" spread="89.6"/>
                    <measurement group_id="O3" value="1350" spread="293"/>
                    <measurement group_id="O4" value="4050" spread="888"/>
                    <measurement group_id="O5" value="7570" spread="634"/>
                    <measurement group_id="O6" value="15100" spread="2830"/>
                    <measurement group_id="O7" value="1400" spread="288"/>
                    <measurement group_id="O8" value="4200" spread="938"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Plasma Concentration Time Curve From Time Zero to the Last Measurable Concentration (AUC0-last) of MT-6345</title>
        <description>AUC(0-last) was computed for MT-6345 for the PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3.</description>
        <time_frame>Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hours. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours.</time_frame>
        <population>PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: MT-6345 1 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O2">
            <title>Part 1: MT-6345 5 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O3">
            <title>Part 1: MT-6345 20 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O4">
            <title>Part 1: MT-6345 60 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O5">
            <title>Part 1: MT-6345 120 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O6">
            <title>Part 1: MT-6345 240 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O7">
            <title>Part 2: MT-6345 20 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O8">
            <title>Part 3: MT-6345 60 mg</title>
            <description>Multiple dose</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Plasma Concentration Time Curve From Time Zero to the Last Measurable Concentration (AUC0-last) of MT-6345</title>
          <description>AUC(0-last) was computed for MT-6345 for the PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3.</description>
          <population>PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3.</population>
          <units>ng.h/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="4"/>
                <count group_id="O6" value="5"/>
                <count group_id="O7" value="5"/>
                <count group_id="O8" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="115" spread="28.6"/>
                    <measurement group_id="O2" value="776" spread="284"/>
                    <measurement group_id="O3" value="3060" spread="1080"/>
                    <measurement group_id="O4" value="11100" spread="2590"/>
                    <measurement group_id="O5" value="21500" spread="8740"/>
                    <measurement group_id="O6" value="41200" spread="20100"/>
                    <measurement group_id="O7" value="3590" spread="1200"/>
                    <measurement group_id="O8" value="4200" spread="938"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-∞) of MT-6345</title>
        <description>AUC(0-∞) was calculated for the PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3.</description>
        <time_frame>Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hour. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours.</time_frame>
        <population>PKPOP subjects in Part 1, Part 2, and on Day 1 in Part 3.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: MT-6345 1 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O2">
            <title>Part 1: MT-6345 5 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O3">
            <title>Part 1: MT-6345 20 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O4">
            <title>Part 1: MT-6345 60 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O5">
            <title>Part 1: MT-6345 120 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O6">
            <title>Part 1: MT-6345 240 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O7">
            <title>Part 2: MT-6345 20 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O8">
            <title>Part 3: MT-6345 60 mg</title>
            <description>Multiple dose</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-∞) of MT-6345</title>
          <description>AUC(0-∞) was calculated for the PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3.</description>
          <population>PKPOP subjects in Part 1, Part 2, and on Day 1 in Part 3.</population>
          <units>ng.h/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="4"/>
                <count group_id="O6" value="5"/>
                <count group_id="O7" value="5"/>
                <count group_id="O8" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="126" spread="31"/>
                    <measurement group_id="O2" value="786" spread="285"/>
                    <measurement group_id="O3" value="3190" spread="1200"/>
                    <measurement group_id="O4" value="11200" spread="2640"/>
                    <measurement group_id="O5" value="21800" spread="9300"/>
                    <measurement group_id="O6" value="42200" spread="21200"/>
                    <measurement group_id="O7" value="3650" spread="1200"/>
                    <measurement group_id="O8" value="9570" spread="3530"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Terminal Elimination Rate Constant (Kel) of MT-6345</title>
        <description>Kel was estimated for the PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3.</description>
        <time_frame>Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hours. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours.</time_frame>
        <population>PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: MT-6345 1 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O2">
            <title>Part 1: MT-6345 5 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O3">
            <title>Part 1: MT-6345 20 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O4">
            <title>Part 1: MT-6345 60 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O5">
            <title>Part 1: MT-6345 120 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O6">
            <title>Part 1: MT-6345 240 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O7">
            <title>Part 2: MT-6345 20 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O8">
            <title>Part 3: MT-6345 60 mg</title>
            <description>Multiple dose</description>
          </group>
        </group_list>
        <measure>
          <title>Terminal Elimination Rate Constant (Kel) of MT-6345</title>
          <description>Kel was estimated for the PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3.</description>
          <population>PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3.</population>
          <units>/h</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="4"/>
                <count group_id="O6" value="5"/>
                <count group_id="O7" value="5"/>
                <count group_id="O8" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0222" spread="0.0081"/>
                    <measurement group_id="O2" value="0.0226" spread="0.0044"/>
                    <measurement group_id="O3" value="0.0208" spread="0.005"/>
                    <measurement group_id="O4" value="0.0166" spread="0.005"/>
                    <measurement group_id="O5" value="0.0176" spread="0.0072"/>
                    <measurement group_id="O6" value="0.0198" spread="0.0104"/>
                    <measurement group_id="O7" value="0.0182" spread="0.0038"/>
                    <measurement group_id="O8" value="0.0244" spread="0.0096"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Residence Time (MRT) of MT-6345</title>
        <description>MRT was calculated for the PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3.</description>
        <time_frame>Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hours. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours.</time_frame>
        <population>PKPOP subjects in Part 1, Part 2 and on Day 1 in Part 3.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: MT-6345 1 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O2">
            <title>Part 1: MT-6345 5 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O3">
            <title>Part 1: MT-6345 20 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O4">
            <title>Part 1: MT-6345 60 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O5">
            <title>Part 1: MT-6345 120 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O6">
            <title>Part 1: MT-6345 240 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O7">
            <title>Part 2: MT-6345 20 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O8">
            <title>Part 3: MT-6345 60 mg</title>
            <description>Multiple dose</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Residence Time (MRT) of MT-6345</title>
          <description>MRT was calculated for the PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3.</description>
          <population>PKPOP subjects in Part 1, Part 2 and on Day 1 in Part 3.</population>
          <units>hour</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="4"/>
                <count group_id="O6" value="5"/>
                <count group_id="O7" value="5"/>
                <count group_id="O8" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.1" spread="16.6"/>
                    <measurement group_id="O2" value="40.8" spread="10"/>
                    <measurement group_id="O3" value="43.9" spread="11.9"/>
                    <measurement group_id="O4" value="57.3" spread="14.5"/>
                    <measurement group_id="O5" value="58.3" spread="28.6"/>
                    <measurement group_id="O6" value="58.8" spread="40.6"/>
                    <measurement group_id="O7" value="50.3" spread="9.52"/>
                    <measurement group_id="O8" value="42.5" spread="11.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Apparent Oral Clearance (CL/F) of MT-6345</title>
        <description>CL/F was measured for MT-6345 in the PKPOP subjects of Part 1 and Part 2, and on Day 1 in Part 3.</description>
        <time_frame>Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hours. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours.</time_frame>
        <population>PKPOP subjects of Part 1, Part 2, and on Day 1 in Part 3.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: MT-6345 1 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O2">
            <title>Part 1: MT-6345 5 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O3">
            <title>Part 1: MT-6345 20 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O4">
            <title>Part 1: MT-6345 60 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O5">
            <title>Part 1: MT-6345 120 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O6">
            <title>Part 1: MT-6345 240 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O7">
            <title>Part 2: MT-6345 20 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O8">
            <title>Part 3: MT-6345 60 mg</title>
            <description>Multiple dose</description>
          </group>
        </group_list>
        <measure>
          <title>Apparent Oral Clearance (CL/F) of MT-6345</title>
          <description>CL/F was measured for MT-6345 in the PKPOP subjects of Part 1 and Part 2, and on Day 1 in Part 3.</description>
          <population>PKPOP subjects of Part 1, Part 2, and on Day 1 in Part 3.</population>
          <units>litre per hour</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="4"/>
                <count group_id="O6" value="5"/>
                <count group_id="O7" value="5"/>
                <count group_id="O8" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.36" spread="1.93"/>
                    <measurement group_id="O2" value="6.89" spread="1.81"/>
                    <measurement group_id="O3" value="7.14" spread="2.93"/>
                    <measurement group_id="O4" value="5.79" spread="2.15"/>
                    <measurement group_id="O5" value="6.16" spread="2.15"/>
                    <measurement group_id="O6" value="7.30" spread="4.17"/>
                    <measurement group_id="O7" value="5.88" spread="1.60"/>
                    <measurement group_id="O8" value="6.92" spread="2.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Plasma Concentration Time Curve Over the Dosing Interval (AUC0-t) of MT-6345.</title>
        <time_frame>up to 2 weeks after dosing</time_frame>
        <population>AUC0-t was not collected, and could not be assessed due to early study termination.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 3: MT-6345 60 mg</title>
            <description>Multiple dose</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Plasma Concentration Time Curve Over the Dosing Interval (AUC0-t) of MT-6345.</title>
          <population>AUC0-t was not collected, and could not be assessed due to early study termination.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Apparent Volume of Distribution at Steady State (Vss/F) of MT-6345</title>
        <description>Vss/F was measured for MT-6345 in the PKPOP subjects of Part 1 and Part 2, and on Day 1 in Part 3.</description>
        <time_frame>Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hours. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours.</time_frame>
        <population>PKPOP subjects of Part 1, Part 2, and on Day 1 in Part 3.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: MT-6345 1 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O2">
            <title>Part 1: MT-6345 5 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O3">
            <title>Part 1: MT-6345 20 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O4">
            <title>Part 1: MT-6345 60 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O5">
            <title>Part 1: MT-6345 120 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O6">
            <title>Part 1: MT-6345 240 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O7">
            <title>Part 2: MT-6345 20 mg</title>
            <description>Single dose</description>
          </group>
          <group group_id="O8">
            <title>Part 3: MT-6345 60 mg</title>
            <description>Multiple dose</description>
          </group>
        </group_list>
        <measure>
          <title>Apparent Volume of Distribution at Steady State (Vss/F) of MT-6345</title>
          <description>Vss/F was measured for MT-6345 in the PKPOP subjects of Part 1 and Part 2, and on Day 1 in Part 3.</description>
          <population>PKPOP subjects of Part 1, Part 2, and on Day 1 in Part 3.</population>
          <units>litre(s)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="4"/>
                <count group_id="O6" value="5"/>
                <count group_id="O7" value="5"/>
                <count group_id="O8" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="335" spread="86.7"/>
                    <measurement group_id="O2" value="271" spread="60.3"/>
                    <measurement group_id="O3" value="286" spread="39.8"/>
                    <measurement group_id="O4" value="318" spread="82.4"/>
                    <measurement group_id="O5" value="314" spread="32.2"/>
                    <measurement group_id="O6" value="319" spread="85.5"/>
                    <measurement group_id="O7" value="284" spread="32.6"/>
                    <measurement group_id="O8" value="280" spread="82.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Linearity Factor (LF) of MT-6345</title>
        <time_frame>up to 2 weeks after dosing</time_frame>
        <population>LF was not collected, and could not be assessed due to early study termination.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 3: MT-6345 60 mg</title>
            <description>Multiple dose</description>
          </group>
        </group_list>
        <measure>
          <title>Linearity Factor (LF) of MT-6345</title>
          <population>LF was not collected, and could not be assessed due to early study termination.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Accumulation Ratio (RA) of MT-6345</title>
        <time_frame>up to 2 weeks after dosing</time_frame>
        <population>RA was not collected, and could not be assessed due to early study termination.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 3: MT-6345 60 mg</title>
            <description>Multiple dose</description>
          </group>
        </group_list>
        <measure>
          <title>Accumulation Ratio (RA) of MT-6345</title>
          <population>RA was not collected, and could not be assessed due to early study termination.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Urinary Excreted Amount of Test Compound (Ae) of MT-6345</title>
        <description>Ae was measured for MT-6345 for the PKPOP subjects in Part 3.</description>
        <time_frame>Day 1 (0 hours to 24 hours) and Day 10 (0 hours to 24 hours)</time_frame>
        <population>PKPOP subjects in Part 3.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 3: MT-6345 60 mg</title>
            <description>Multiple dose</description>
          </group>
        </group_list>
        <measure>
          <title>Urinary Excreted Amount of Test Compound (Ae) of MT-6345</title>
          <description>Ae was measured for MT-6345 for the PKPOP subjects in Part 3.</description>
          <population>PKPOP subjects in Part 3.</population>
          <units>milligram(s)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.160" spread="0.0440"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.255" spread="0.102"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Urinary Excreted Amount of Test Compound Expressed as a Percentage of the Dose Administered (Ae%) of MT-6345</title>
        <description>Ae% was measured for MT-6345 for the PKPOP subjects in Part 3.</description>
        <time_frame>Day 1 (pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 16 hours) and Day 2 to Day 10 (pre-dose on each day)</time_frame>
        <population>PKPOP subjects in Part 3.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 3: MT-6345 60 mg</title>
            <description>Multiple dose</description>
          </group>
        </group_list>
        <measure>
          <title>Urinary Excreted Amount of Test Compound Expressed as a Percentage of the Dose Administered (Ae%) of MT-6345</title>
          <description>Ae% was measured for MT-6345 for the PKPOP subjects in Part 3.</description>
          <population>PKPOP subjects in Part 3.</population>
          <units>percentage of dose</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Renal Clearance (CLR) of MT-6345</title>
        <description>CLR was measured for MT-6345 for the PKPOP subjects in Part 3. For Day 10, CLR was not calculated because AUC(0-24h) on the last day of dosing was not calculated.</description>
        <time_frame>Day 1 (0 hours to 24 hours) and Day 10 (0 hours to 24 hours)</time_frame>
        <population>PKPOP subjects in Part 3.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 3: MT-6345 60 mg</title>
            <description>Multiple dose</description>
          </group>
        </group_list>
        <measure>
          <title>Renal Clearance (CLR) of MT-6345</title>
          <description>CLR was measured for MT-6345 for the PKPOP subjects in Part 3. For Day 10, CLR was not calculated because AUC(0-24h) on the last day of dosing was not calculated.</description>
          <population>PKPOP subjects in Part 3.</population>
          <units>L/h</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0390" spread="0.0110"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Part 1 Placebo</title>
          <description>Single dose</description>
        </group>
        <group group_id="E2">
          <title>Part 1: MT-6345 1 mg</title>
          <description>Single dose</description>
        </group>
        <group group_id="E3">
          <title>Part 1: MT-6345 5 mg</title>
          <description>Single dose</description>
        </group>
        <group group_id="E4">
          <title>Part 1: MT-6345 20 mg</title>
          <description>Single dose</description>
        </group>
        <group group_id="E5">
          <title>Part 1: MT-6345 60 mg</title>
          <description>Single dose</description>
        </group>
        <group group_id="E6">
          <title>Part 1: MT-6345 120 mg</title>
          <description>Single dose</description>
        </group>
        <group group_id="E7">
          <title>Part 1: MT-6345 240 mg</title>
          <description>Single dose</description>
        </group>
        <group group_id="E8">
          <title>Part 2: Placebo</title>
          <description>Single dose</description>
        </group>
        <group group_id="E9">
          <title>Part 2: MT-6345 20 mg</title>
          <description>Single dose</description>
        </group>
        <group group_id="E10">
          <title>Part 3: Placebo</title>
          <description>Multiple dose</description>
        </group>
        <group group_id="E11">
          <title>Part 3: MT-6345 60 mg</title>
          <description>Multiple dose</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 21.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Abdominal tenderness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Medical device site reaction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperbilirubinaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Fungal skin infections</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Skin abrasion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Petechiae</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Trials, Information Desk</name_or_title>
      <organization>Mitsubishi Tanabe Pharma Europe Ltd</organization>
      <phone>Please e-mail</phone>
      <email>regulatory@mt-pharma-eu.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03809039
org study id: MT-6345-E01
secondary id: 2018-002478-39
nct id: NCT03809039
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to Investigate the Safety, Tolerability and Pharmacokinetics of
      MT-6345 in Healthy Subjects.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of Participants With Mild, Moderate and Severe Adverse Events
time frame: Up to 6 weeks
description: The criteria of Mild, Moderate and Severe are as follows:
Mild: The event is transient and easily tolerated by the subject.
Moderate: The event causes discomfort and interferes with the subject's general condition.
Severe: The event causes considerable interference with the subject's general condition and may be incapacitating.
measure: Maximum Plasma Concentration (Cmax) of MT-6345
time frame: Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hours. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours.
description: Cmax was measured for MT-6345 for the PK analysis set (PKPOP) subjects in Part 1 and Part 2, and on Day 1 in Part 3.
measure: Time to Maximum Plasma Concentration (Tmax) of MT-6345
time frame: Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hours. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours.
description: Tmax was measured for MT-6345 for the PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3.
measure: Plasma Terminal Elimination Half Life (t½) of MT-6345
time frame: Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hours. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours.
description: t1/2 was measured for MT-6345 for the PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3.
measure: Area Under the Plasma Concentration Time Curve From Time Zero to 24 Hours (AUC0-24h) of MT-6345
time frame: Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hours. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours.
description: AUC(0-24h) was computed for MT-6345 for the PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3.
measure: Area Under the Plasma Concentration Time Curve From Time Zero to the Last Measurable Concentration (AUC0-last) of MT-6345
time frame: Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hours. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours.
description: AUC(0-last) was computed for MT-6345 for the PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3.
measure: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-∞) of MT-6345
time frame: Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hour. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours.
description: AUC(0-∞) was calculated for the PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3.
measure: Terminal Elimination Rate Constant (Kel) of MT-6345
time frame: Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hours. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours.
description: Kel was estimated for the PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3.
measure: Mean Residence Time (MRT) of MT-6345
time frame: Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hours. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours.
description: MRT was calculated for the PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3.
measure: Apparent Oral Clearance (CL/F) of MT-6345
time frame: Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hours. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours.
description: CL/F was measured for MT-6345 in the PKPOP subjects of Part 1 and Part 2, and on Day 1 in Part 3.
measure: Area Under the Plasma Concentration Time Curve Over the Dosing Interval (AUC0-t) of MT-6345.
time frame: up to 2 weeks after dosing
measure: Apparent Volume of Distribution at Steady State (Vss/F) of MT-6345
time frame: Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hours. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours.
description: Vss/F was measured for MT-6345 in the PKPOP subjects of Part 1 and Part 2, and on Day 1 in Part 3.
measure: Linearity Factor (LF) of MT-6345
time frame: up to 2 weeks after dosing
measure: Accumulation Ratio (RA) of MT-6345
time frame: up to 2 weeks after dosing
measure: Urinary Excreted Amount of Test Compound (Ae) of MT-6345
time frame: Day 1 (0 hours to 24 hours) and Day 10 (0 hours to 24 hours)
description: Ae was measured for MT-6345 for the PKPOP subjects in Part 3.
measure: Urinary Excreted Amount of Test Compound Expressed as a Percentage of the Dose Administered (Ae%) of MT-6345
time frame: Day 1 (pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 16 hours) and Day 2 to Day 10 (pre-dose on each day)
description: Ae% was measured for MT-6345 for the PKPOP subjects in Part 3.
measure: Renal Clearance (CLR) of MT-6345
time frame: Day 1 (0 hours to 24 hours) and Day 10 (0 hours to 24 hours)
description: CLR was measured for MT-6345 for the PKPOP subjects in Part 3. For Day 10, CLR was not calculated because AUC(0-24h) on the last day of dosing was not calculated.
arm group label: Single Ascending Dose: MT-6345 & Placebo
arm group type: Experimental
arm group label: Multiple Ascending Dose: MT-6345 & Placebo
arm group type: Experimental
intervention type: Drug
intervention name: MT-6345
description: MT-6345
arm group label: Multiple Ascending Dose: MT-6345 & Placebo
arm group label: Single Ascending Dose: MT-6345 & Placebo
intervention type: Drug
intervention name: MT-6345 Placebo
description: MT-6345 Placebo
arm group label: Multiple Ascending Dose: MT-6345 & Placebo
arm group label: Single Ascending Dose: MT-6345 & Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Head of Medical Science,
role: Study Director
affiliation: Mitsubishi Tanabe Pharma America Inc.
facility: 
country: United Kingdom
responsible party type: Sponsor
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 