<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/NCT04486950</url>
  </required_header>
  <id_info>
    <org_study_id>TAK-951-1004</org_study_id>
    <secondary_id>U1111-1251-9214</secondary_id>
    <nct_id>NCT04486950</nct_id>
  </id_info>
  <brief_title>A Study of TAK-951 in Healthy Adults</brief_title>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TAK-951 in Healthy Subjects Following Intravenous Administration</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Takeda</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Takeda</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      It is hoped that a medicine called TAK-951 will eventually be used to treat nausea and&#xD;
      vomiting. Before then, the sponsor needs to understand how the body processes TAK-951 in&#xD;
      healthy adults.&#xD;
&#xD;
      The main aims of this study are as follows:&#xD;
&#xD;
        -  To check for side effects from TAK-951 when given at a slow and fast infusion rate.&#xD;
&#xD;
        -  To learn how much TAK-951 participants can receive without getting side effects from it.&#xD;
&#xD;
      Participants will receive a single infusion of either TAK-951 or placebo. In this study, a&#xD;
      placebo looks like TAK-951 but does not have any medicine in it. Participants will receive&#xD;
      either a low dose or high dose of TAK-951. The infusion will take from 1-3 hours.&#xD;
&#xD;
      Participants will stay in the study clinic for about 4 days to receive the study medicine&#xD;
      (TAK-951 or placebo) and check for side effects. They will have follow-up visits at the&#xD;
      clinic about 2 weeks and 4 weeks after treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The drug being tested in this study is called TAK-951. The study will evaluate the safety,&#xD;
      tolerability and PK of TAK-951 in healthy participants.&#xD;
&#xD;
      The study will enroll approximately 40 healthy participants. Each cohort will have 8&#xD;
      participants to be randomized and a minimum of 3 cohorts will be evaluated. Participants will&#xD;
      be randomly assigned (by chance, like flipping a coin) to receive TAK-951 or placebo in a 6:2&#xD;
      ratio in one of the following 3 cohorts, which will remain undisclosed to the participant and&#xD;
      study doctor during the study (unless there is an urgent medical need):&#xD;
&#xD;
        -  Cohort 1 (Low Dose): TAK-951 20 mcg Infusion Over 60 Minutes&#xD;
&#xD;
        -  Cohort 2 (High Dose): TAK-951 1 mg Infusion Over 60 Minutes&#xD;
&#xD;
        -  Cohort 3: TAK-951 1 mg Infusion over 120 Minutes&#xD;
&#xD;
      Sentinel dosing will be done in first 2 participants in each cohort. The dosing in rest of&#xD;
      the cohort will done if there are no significant safety or tolerability concerns. Additional&#xD;
      2 cohorts, each cohort with 8 participants may be added in study to evaluate additional&#xD;
      intravenous dosing regimen after clinical data analysis of first 3 cohorts. Dosing of the&#xD;
      subsequent cohort will be based on the analysis of the previous cohort's data.&#xD;
&#xD;
      This single-center trial will be conducted in the United States. The overall time to&#xD;
      participate in this study is up to 57 days. All participants will return to clinic after 14&#xD;
      and 28 days after the last visit to the clinic for a follow-up assessment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 7, 2020</start_date>
  <completion_date type="Actual">May 27, 2021</completion_date>
  <primary_completion_date type="Actual">May 16, 2021</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 Who Reported One or More Treatment-emergent Adverse Events (TEAEs)</measure>
    <time_frame>Baseline up to Day 29</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Clinically Significant Change From Baseline in Vital Sign Values</measure>
    <time_frame>Baseline up to Day 2</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Clinically Significant Change From Baseline in 12- Lead Electrocardiogram (ECG) Values</measure>
    <time_frame>Baseline up to Day 2</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Clinically Significant Change From Baseline in Laboratory Values</measure>
    <time_frame>Baseline up to Day 2</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Clinically Significant Change From Baseline in Physical Examination Values</measure>
    <time_frame>Baseline up to Day 29</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-951</measure>
    <time_frame>Day 1 pre-dose and at multiple time points (up to 30 hours) post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ceoi: Plasma Concentration at the End of Infusion for TAK-951</measure>
    <time_frame>Day 1: at the end of infusion (at 30 hours post-infusion)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-951</measure>
    <time_frame>Day 1 pre-dose and at multiple time points (up to 30 hours) post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>T1/2z: Terminal Disposition Phase Half-life for TAK-951</measure>
    <time_frame>Day 1 pre-dose and at multiple time points (up to 30 hours) post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>λz: Terminal Disposition Phase Rate Constant for TAK-951</measure>
    <time_frame>Day 1 pre-dose and at multiple time points (up to 30 hours) post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Positive Anti-drug Antibodies (ADA) in Serum</measure>
    <time_frame>Baseline up to Day 29</time_frame>
    <description>ADA positive was defined as a sample that was evaluated as positive in both the ADA screening and confirmatory assays. ADA positive participants was defined as participants who had at least 1 positive ADA result.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Healthy Volunteer</condition>
  <arm_group>
    <arm_group_label>Cohort 1 (Low Dose): TAK-951 20 mcg Infusion Over 60 Minutes</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAK-951 20 microgram (mcg) or TAK-951 placebo-matching, infusion, intravenously, over a period of 60 minutes on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2 (High Dose): TAK-951 1 mg Infusion Over 60 Minutes</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAK-951 1 milligram (mg) or TAK-951 placebo-matching, infusion, intravenously, over a period of 60 minutes on Day 1. Dose level will be determined based on safety, tolerability and PK data from previous cohorts.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 3: TAK-951 1 mg Infusion Over 120 Minutes</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAK-951 1 mg or TAK-951 placebo-matching, infusion, intravenously, over a period of 120 minutes on Day 1. Dose level will be determined based on safety, tolerability and PK data from previous cohorts.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TAK-951</intervention_name>
    <description>TAK-951 intravenous infusion.</description>
    <arm_group_label>Cohort 1 (Low Dose): TAK-951 20 mcg Infusion Over 60 Minutes</arm_group_label>
    <arm_group_label>Cohort 2 (High Dose): TAK-951 1 mg Infusion Over 60 Minutes</arm_group_label>
    <arm_group_label>Cohort 3: TAK-951 1 mg Infusion Over 120 Minutes</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TAK-951 Placebo</intervention_name>
    <description>TAK-951 placebo-matching intravenous infusion.</description>
    <arm_group_label>Cohort 1 (Low Dose): TAK-951 20 mcg Infusion Over 60 Minutes</arm_group_label>
    <arm_group_label>Cohort 2 (High Dose): TAK-951 1 mg Infusion Over 60 Minutes</arm_group_label>
    <arm_group_label>Cohort 3: TAK-951 1 mg Infusion Over 120 Minutes</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Continuous non-smoker who has not used nicotine- and tobacco-containing products&#xD;
             and/or cannabis products for at least 3 months prior to dosing and throughout the&#xD;
             study.&#xD;
&#xD;
          2. Body mass index (BMI) greater than or equal to (&gt;=) 18.0 and less than or equal to&#xD;
             (&lt;=) 32.0 kilogram per square meter (kg/m^2) at screening.&#xD;
&#xD;
          3. Female must be of non-childbearing potential.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Is mentally or legally incapacitated or has significant emotional problems at the time&#xD;
             of the screening visit or expected during the conduct of the study.&#xD;
&#xD;
          2. Drink alcohol in excess of 21 glasses/units per week for males or 14 glasses/units per&#xD;
             week for females, with one unit equal to (=) 150 milliliter (mL) of wine or 360 mL of&#xD;
             beer or 45 mL of 45 percent (%) alcohol.&#xD;
&#xD;
          3. Have any tattoos, scars or skin issue at planned IV infusion site which could&#xD;
             interfere with dosing.&#xD;
&#xD;
          4. History or presence of:&#xD;
&#xD;
               -  Three (3) or more incidences of vasovagal syncope within the last 5 years prior&#xD;
                  to screening.&#xD;
&#xD;
               -  Family history of unexplained sudden death or channelopathy.&#xD;
&#xD;
               -  Brugada syndrome (that is, right bundle branch block (RBBB) pattern with&#xD;
                  ST-elevation in leads V1-V3).&#xD;
&#xD;
               -  Cardiovascular or cerebrovascular disease, such as cardiac valvulopathy,&#xD;
                  myocardial infarction, stroke, sick sinus syndrome, pulmonary congestion,&#xD;
                  symptomatic or significant cardiac arrhythmia, second-degree AV block type 2,&#xD;
                  third-degree AV block, prolonged corrected QT interval by Fredericia (QTcF)&#xD;
                  interval, hypokalemia, hypomagnesemia, or conduction abnormalities;&#xD;
&#xD;
               -  Risk factors for Torsade de Pointes (example, heart failure, cardiomyopathy, or&#xD;
                  family history of Long QT Syndrome);&#xD;
&#xD;
               -  Any clinically significant ECG findings or medical history including: long or&#xD;
                  short QT interval with QTcF (over 450 msec or less than 360 msec), bifascicular&#xD;
                  block or QRS &gt;=120 msec or PR interval greater than (&gt;) 200 msec at screening or&#xD;
                  Day -1 pre-Hour 0.&#xD;
&#xD;
               -  Documented history of sinoatrial block or sinus pause &gt;=3 seconds.&#xD;
&#xD;
          5. Semi-recumbent blood pressure (average of duplicate) is less than 90/60 millimeter of&#xD;
             mercury (mmHg) or greater than 140/90 mmHg at screening.&#xD;
&#xD;
          6. Has an average semi-recumbent heart rate &lt;60 or &gt;100 beats per minute (bpm) (at&#xD;
             screening, at Day -1 pre-Hour 0, or at pre-dose Day 1); athletic participants with an&#xD;
             average semi-recumbent heart rate &lt;60 bpm can be enrolled only with medical monitor&#xD;
             approval. If participant has heart rate &lt;60 bpm Investigator should obtain medical&#xD;
             approval from Sponsor.&#xD;
&#xD;
          7. Has orthostatic hypotension defined as a decrease in systolic blood pressure &gt;=20 mmHg&#xD;
             or a decrease in diastolic blood pressure &gt;=10 mmHg after 2 minutes of standing when&#xD;
             compared with blood pressure from the semi-recumbent position at screening and at Day&#xD;
             -1 pre-Hour 0. The semi-recumbent blood pressure will be an average of duplicate&#xD;
             measurements.&#xD;
&#xD;
          8. Has postural orthostatic tachycardia, defined as an increase of 30 bpm or heart rate&#xD;
             &gt;120 bpm after standing for 2 minutes.&#xD;
&#xD;
          9. Positive urine drug or alcohol results at screening or check-in.&#xD;
&#xD;
         10. Positive urine cotinine at screening or check-in.&#xD;
&#xD;
         11. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B&#xD;
             surface antigen (HBsAg), or hepatitis C virus (HCV).&#xD;
&#xD;
         12. Unable to refrain from or anticipates the use of any drug, including prescription and&#xD;
             non-prescription medications, herbal remedies, or vitamin supplements beginning 14&#xD;
             days prior to dosing and throughout the study. Thyroid hormone replacement medication&#xD;
             may be permitted if the participant has been on same stable dose for the last 3 months&#xD;
             prior to study drug administration. After dosing, acetaminophen (up to 2 g per 24&#xD;
             hours) may be administered at the discretion of the Investigator or designee. Hormone&#xD;
             replacement therapy will also be allowed.&#xD;
&#xD;
         13. Has been on a diet incompatible with the on-study diet, in the opinion of the&#xD;
             Investigator or designee, within the 30 days prior to dosing and throughout the study.&#xD;
&#xD;
         14. Donation of blood or significant blood loss within 56 days prior to dosing.&#xD;
&#xD;
         15. Plasma donation within 7 days prior to dosing.&#xD;
&#xD;
         16. Has positive results for Coronavirus disease 2019 (COVID-19) testing at screening or&#xD;
             check-in.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Takeda</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Celerion</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://clinicaltrials.takeda.com/study-detail/5f6b603d4db2bf003ab4a3c0</url>
    <description>To obtain more information on the study, click here/on this link</description>
  </link>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <results_first_submitted>May 9, 2022</results_first_submitted>
  <results_first_submitted_qc>February 24, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">March 10, 2023</results_first_posted>
  <last_update_submitted>February 24, 2023</last_update_submitted>
  <last_update_submitted_qc>February 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Drug Therapy</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_access_criteria>IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.</ipd_access_criteria>
    <ipd_url>https://vivli.org/ourmember/takeda/</ipd_url>
  </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>January 8, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/50/NCT04486950/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>May 13, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/50/NCT04486950/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants took part in the study at 1 investigative site in the United States from 07 July 2020 to 27 May 2021.</recruitment_details>
      <pre_assignment_details>Healthy participants were randomized and treated sequentially in Cohorts: 1, 2, 3 and 4 to receive intravenous infusion of TAK-951 20 microgram (mcg), TAK-951 1.0 milligram (mg) or TAK-951 matching placebo (normal saline).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Cohorts 1 to 2, Treatment P1: Placebo Pooled</title>
          <description>TAK-951 placebo-matching (0.2 milliliter [ml] normal saline), infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.</description>
        </group>
        <group group_id="P2">
          <title>Cohort 3, Treatment P2: Placebo</title>
          <description>TAK-951 placebo-matching (1 ml normal saline), infusion, intravenously over 120 minutes in fasted condition once on Day 1 in healthy participants.</description>
        </group>
        <group group_id="P3">
          <title>Cohort 4, Treatment P3: Placebo</title>
          <description>TAK-951 placebo-matching (1 ml normal saline), infusion, intravenously over 180 minutes in fasted condition once on Day 1 in healthy participants.</description>
        </group>
        <group group_id="P4">
          <title>Cohort 1, Treatment A: TAK-951 20 mcg</title>
          <description>TAK-951 20 mcg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.</description>
        </group>
        <group group_id="P5">
          <title>Cohort 2, Treatment B: TAK-951 1.0 mg</title>
          <description>TAK-951 1.0 mg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.</description>
        </group>
        <group group_id="P6">
          <title>Cohort 3, Treatment C: TAK-951 1.0 mg</title>
          <description>TAK-951 1.0 mg, infusion, intravenously over 120 minutes in fasted condition once on Day 1 in healthy participants.</description>
        </group>
        <group group_id="P7">
          <title>Cohort 4, Treatment D: TAK-951 1.0 mg</title>
          <description>TAK-951 1.0 mg, infusion, intravenously over 180 minutes in fasted condition once on Day 1 in healthy participants.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="6"/>
                <participants group_id="P7" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="5"/>
                <participants group_id="P7" count="6"/>
              </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="1"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</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="1"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The safety analysis set consisted of all participants who were enrolled and received the full or partial dose of study drug or placebo.</population>
      <group_list>
        <group group_id="B1">
          <title>Cohorts 1 to 2, Treatment P1: Placebo Pooled</title>
          <description>TAK-951 placebo-matching (0.2 ml normal saline), infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.</description>
        </group>
        <group group_id="B2">
          <title>Cohort 3, Treatment P2: Placebo</title>
          <description>TAK-951 placebo-matching (1 ml normal saline), infusion, intravenously over 120 minutes in fasted condition once on Day 1 in healthy participants.</description>
        </group>
        <group group_id="B3">
          <title>Cohort 4, Treatment P3: Placebo</title>
          <description>TAK-951 placebo-matching (1 ml normal saline), infusion, intravenously over 180 minutes in fasted condition once on Day 1 in healthy participants.</description>
        </group>
        <group group_id="B4">
          <title>Cohort 1, Treatment A: TAK-951 20 mcg</title>
          <description>TAK-951 20 mcg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.</description>
        </group>
        <group group_id="B5">
          <title>Cohort 2, Treatment B: TAK-951 1.0 mg</title>
          <description>TAK-951 1.0 mg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.</description>
        </group>
        <group group_id="B6">
          <title>Cohort 3, Treatment C: TAK-951 1.0 mg</title>
          <description>TAK-951 1.0 mg, infusion, intravenously over 120 minutes in fasted condition once on Day 1 in healthy participants.</description>
        </group>
        <group group_id="B7">
          <title>Cohort 4, Treatment D: TAK-951 1.0 mg</title>
          <description>TAK-951 1.0 mg, infusion, intravenously over 180 minutes in fasted condition once on Day 1 in healthy participants.</description>
        </group>
        <group group_id="B8">
          <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="4"/>
            <count group_id="B2" value="2"/>
            <count group_id="B3" value="2"/>
            <count group_id="B4" value="6"/>
            <count group_id="B5" value="6"/>
            <count group_id="B6" value="6"/>
            <count group_id="B7" value="6"/>
            <count group_id="B8" value="32"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</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_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="6"/>
                    <measurement group_id="B7" value="6"/>
                    <measurement group_id="B8" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</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_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="2"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="5"/>
                    <measurement group_id="B7" value="6"/>
                    <measurement group_id="B8" value="29"/>
                  </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="1"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="5"/>
                    <measurement group_id="B7" value="4"/>
                    <measurement group_id="B8" value="29"/>
                  </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_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_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="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="1"/>
                  </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_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="5"/>
                    <measurement group_id="B6" value="4"/>
                    <measurement group_id="B7" value="6"/>
                    <measurement group_id="B8" value="25"/>
                  </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="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="1"/>
                  </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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="6"/>
                    <measurement group_id="B7" value="6"/>
                    <measurement group_id="B8" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Reported One or More Treatment-emergent Adverse Events (TEAEs)</title>
        <time_frame>Baseline up to Day 29</time_frame>
        <population>The safety analysis set consisted of all participants who were enrolled and received the full or partial dose of study drug or placebo.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohorts 1 to 2, Treatment P1: Placebo Pooled</title>
            <description>TAK-951 placebo-matching (0.2 ml normal saline), infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 3, Treatment P2: Placebo</title>
            <description>TAK-951 placebo-matching (1 ml normal saline), infusion, intravenously over 120 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 4, Treatment P3: Placebo</title>
            <description>TAK-951 placebo-matching (1 ml normal saline), infusion, intravenously over 180 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 1, Treatment A: TAK-951 20 mcg</title>
            <description>TAK-951 20 mcg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
          <group group_id="O5">
            <title>Cohort 2, Treatment B: TAK-951 1.0 mg</title>
            <description>TAK-951 1.0 mg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
          <group group_id="O6">
            <title>Cohort 3, Treatment C: TAK-951 1.0 mg</title>
            <description>TAK-951 1.0 mg, infusion, intravenously over 120 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
          <group group_id="O7">
            <title>Cohort 4, Treatment D: TAK-951 1.0 mg</title>
            <description>TAK-951 1.0 mg, infusion, intravenously over 180 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Reported One or More Treatment-emergent Adverse Events (TEAEs)</title>
          <population>The safety analysis set consisted of all participants who were enrolled and received the full or partial dose of study drug or placebo.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="2"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="3"/>
                    <measurement group_id="O7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Clinically Significant Change From Baseline in Vital Sign Values</title>
        <time_frame>Baseline up to Day 2</time_frame>
        <population>The safety analysis set consisted of all participants who were enrolled and received the full or partial dose of study drug or placebo.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohorts 1 to 2, Treatment P1: Placebo Pooled</title>
            <description>TAK-951 placebo-matching (0.2 ml normal saline), infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 3, Treatment P2: Placebo</title>
            <description>TAK-951 placebo-matching (1 ml normal saline), infusion, intravenously over 120 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 4, Treatment P3: Placebo</title>
            <description>TAK-951 placebo-matching (1 ml normal saline), infusion, intravenously over 180 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 1, Treatment A: TAK-951 20 mcg</title>
            <description>TAK-951 20 mcg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
          <group group_id="O5">
            <title>Cohort 2, Treatment B: TAK-951 1.0 mg</title>
            <description>TAK-951 1.0 mg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
          <group group_id="O6">
            <title>Cohort 3, Treatment C: TAK-951 1.0 mg</title>
            <description>TAK-951 1.0 mg, infusion, intravenously over 120 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
          <group group_id="O7">
            <title>Cohort 4, Treatment D: TAK-951 1.0 mg</title>
            <description>TAK-951 1.0 mg, infusion, intravenously over 180 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Change From Baseline in Vital Sign Values</title>
          <population>The safety analysis set consisted of all participants who were enrolled and received the full or partial dose of study drug or placebo.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="2"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Clinically Significant Change From Baseline in 12- Lead Electrocardiogram (ECG) Values</title>
        <time_frame>Baseline up to Day 2</time_frame>
        <population>The safety analysis set consisted of all participants who were enrolled and received the full or partial dose of study drug or placebo.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohorts 1 to 2, Treatment P1: Placebo Pooled</title>
            <description>TAK-951 placebo-matching (0.2 ml normal saline), infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 3, Treatment P2: Placebo</title>
            <description>TAK-951 placebo-matching (1 ml normal saline), infusion, intravenously over 120 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 4, Treatment P3: Placebo</title>
            <description>TAK-951 placebo-matching (1 ml normal saline), infusion, intravenously over 180 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 1, Treatment A: TAK-951 20 mcg</title>
            <description>TAK-951 20 mcg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
          <group group_id="O5">
            <title>Cohort 2, Treatment B: TAK-951 1.0 mg</title>
            <description>TAK-951 1.0 mg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
          <group group_id="O6">
            <title>Cohort 3, Treatment C: TAK-951 1.0 mg</title>
            <description>TAK-951 1.0 mg, infusion, intravenously over 120 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
          <group group_id="O7">
            <title>Cohort 4, Treatment D: TAK-951 1.0 mg</title>
            <description>TAK-951 1.0 mg, infusion, intravenously over 180 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Change From Baseline in 12- Lead Electrocardiogram (ECG) Values</title>
          <population>The safety analysis set consisted of all participants who were enrolled and received the full or partial dose of study drug or placebo.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="2"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Clinically Significant Change From Baseline in Laboratory Values</title>
        <time_frame>Baseline up to Day 2</time_frame>
        <population>The safety analysis set consisted of all participants who were enrolled and received the full or partial dose of study drug or placebo.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohorts 1 to 2, Treatment P1: Placebo Pooled</title>
            <description>TAK-951 placebo-matching (0.2 ml normal saline), infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 3, Treatment P2: Placebo</title>
            <description>TAK-951 placebo-matching (1 ml normal saline), infusion, intravenously over 120 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 4, Treatment P3: Placebo</title>
            <description>TAK-951 placebo-matching (1 ml normal saline), infusion, intravenously over 180 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 1, Treatment A: TAK-951 20 mcg</title>
            <description>TAK-951 20 mcg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
          <group group_id="O5">
            <title>Cohort 2, Treatment B: TAK-951 1.0 mg</title>
            <description>TAK-951 1.0 mg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
          <group group_id="O6">
            <title>Cohort 3, Treatment C: TAK-951 1.0 mg</title>
            <description>TAK-951 1.0 mg, infusion, intravenously over 120 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
          <group group_id="O7">
            <title>Cohort 4, Treatment D: TAK-951 1.0 mg</title>
            <description>TAK-951 1.0 mg, infusion, intravenously over 180 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Change From Baseline in Laboratory Values</title>
          <population>The safety analysis set consisted of all participants who were enrolled and received the full or partial dose of study drug or placebo.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="2"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Clinically Significant Change From Baseline in Physical Examination Values</title>
        <time_frame>Baseline up to Day 29</time_frame>
        <population>The safety analysis set consisted of all participants who were enrolled and received the full or partial dose of study drug or placebo.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohorts 1 to 2, Treatment P1: Placebo Pooled</title>
            <description>TAK-951 placebo-matching (0.2 ml normal saline), infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 3, Treatment P2: Placebo</title>
            <description>TAK-951 placebo-matching (1 ml normal saline), infusion, intravenously over 120 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 4, Treatment P3: Placebo</title>
            <description>TAK-951 placebo-matching (1 ml normal saline), infusion, intravenously over 180 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 1, Treatment A: TAK-951 20 mcg</title>
            <description>TAK-951 20 mcg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
          <group group_id="O5">
            <title>Cohort 2, Treatment B: TAK-951 1.0 mg</title>
            <description>TAK-951 1.0 mg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
          <group group_id="O6">
            <title>Cohort 3, Treatment C: TAK-951 1.0 mg</title>
            <description>TAK-951 1.0 mg, infusion, intravenously over 120 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
          <group group_id="O7">
            <title>Cohort 4, Treatment D: TAK-951 1.0 mg</title>
            <description>TAK-951 1.0 mg, infusion, intravenously over 180 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Change From Baseline in Physical Examination Values</title>
          <population>The safety analysis set consisted of all participants who were enrolled and received the full or partial dose of study drug or placebo.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="2"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-951</title>
        <time_frame>Day 1 pre-dose and at multiple time points (up to 30 hours) post-dose</time_frame>
        <population>The pharmacokinetic (PK) analysis set consisted of all participants who received the active study drug and had at least one measurable plasma concentration of TAK-951.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, Treatment A: TAK-951 20 mcg</title>
            <description>TAK-951 20 mcg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, Treatment B: TAK-951 1.0 mg</title>
            <description>TAK-951 1.0 mg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, Treatment C: TAK-951 1.0 mg</title>
            <description>TAK-951 1.0 mg, infusion, intravenously over 120 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4, Treatment D: TAK-951 1.0 mg</title>
            <description>TAK-951 1.0 mg, infusion, intravenously over 180 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
        </group_list>
        <measure>
          <title>AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-951</title>
          <population>The pharmacokinetic (PK) analysis set consisted of all participants who received the active study drug and had at least one measurable plasma concentration of TAK-951.</population>
          <units>nanogram*hour per milliliter (ng*hr/mL)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</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_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.758" spread="25.1"/>
                    <measurement group_id="O2" value="110.4" spread="11.0"/>
                    <measurement group_id="O3" value="127.7" spread="23.9"/>
                    <measurement group_id="O4" value="133.2" spread="9.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ceoi: Plasma Concentration at the End of Infusion for TAK-951</title>
        <time_frame>Day 1: at the end of infusion (at 30 hours post-infusion)</time_frame>
        <population>The PK analysis set consisted of all participants who received the active study drug and had at least one measurable plasma concentration of TAK-951. Here &quot;overall number of participants&quot; analyzed are those who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, Treatment A: TAK-951 20 mcg</title>
            <description>TAK-951 20 mcg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, Treatment B: TAK-951 1.0 mg</title>
            <description>TAK-951 1.0 mg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, Treatment C: TAK-951 1.0 mg</title>
            <description>TAK-951 1.0 mg, infusion, intravenously over 120 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4, Treatment D: TAK-951 1.0 mg</title>
            <description>TAK-951 1.0 mg, infusion, intravenously over 180 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
        </group_list>
        <measure>
          <title>Ceoi: Plasma Concentration at the End of Infusion for TAK-951</title>
          <population>The PK analysis set consisted of all participants who received the active study drug and had at least one measurable plasma concentration of TAK-951. Here &quot;overall number of participants&quot; analyzed are those who were evaluable for this outcome measure.</population>
          <units>nanogram per milliliter (ng/mL)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</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="5"/>
                <count group_id="O4" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5203" spread="143.2"/>
                    <measurement group_id="O2" value="48.95" spread="15.9"/>
                    <measurement group_id="O3" value="37.03" spread="38.4"/>
                    <measurement group_id="O4" value="27.06" spread="9.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-951</title>
        <time_frame>Day 1 pre-dose and at multiple time points (up to 30 hours) post-dose</time_frame>
        <population>The PK analysis set consisted of all participants who received the active study drug and had at least one measurable plasma concentration of TAK-951.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, Treatment A: TAK-951 20 mcg</title>
            <description>TAK-951 20 mcg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, Treatment B: TAK-951 1.0 mg</title>
            <description>TAK-951 1.0 mg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, Treatment C: TAK-951 1.0 mg</title>
            <description>TAK-951 1.0 mg, infusion, intravenously over 120 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4, Treatment D: TAK-951 1.0 mg</title>
            <description>TAK-951 1.0 mg, infusion, intravenously over 180 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
        </group_list>
        <measure>
          <title>AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-951</title>
          <population>The PK analysis set consisted of all participants who received the active study drug and had at least one measurable plasma concentration of TAK-951.</population>
          <units>ng*hr/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</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_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.722" spread="25.4"/>
                    <measurement group_id="O2" value="110.0" spread="10.8"/>
                    <measurement group_id="O3" value="127.2" spread="24.0"/>
                    <measurement group_id="O4" value="132.5" spread="9.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>T1/2z: Terminal Disposition Phase Half-life for TAK-951</title>
        <time_frame>Day 1 pre-dose and at multiple time points (up to 30 hours) post-dose</time_frame>
        <population>The PK analysis set consisted of all participants who received the active study drug and had at least one measurable plasma concentration of TAK-951.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, Treatment A: TAK-951 20 mcg</title>
            <description>TAK-951 20 mcg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, Treatment B: TAK-951 1.0 mg</title>
            <description>TAK-951 1.0 mg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, Treatment C: TAK-951 1.0 mg</title>
            <description>TAK-951 1.0 mg, infusion, intravenously over 120 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4, Treatment D: TAK-951 1.0 mg</title>
            <description>TAK-951 1.0 mg, infusion, intravenously over 180 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
        </group_list>
        <measure>
          <title>T1/2z: Terminal Disposition Phase Half-life for TAK-951</title>
          <population>The PK analysis set consisted of all participants who received the active study drug and had at least one measurable plasma concentration of TAK-951.</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_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.025" spread="0.7100"/>
                    <measurement group_id="O2" value="4.670" spread="0.5576"/>
                    <measurement group_id="O3" value="4.454" spread="0.5124"/>
                    <measurement group_id="O4" value="4.640" spread="0.3410"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>λz: Terminal Disposition Phase Rate Constant for TAK-951</title>
        <time_frame>Day 1 pre-dose and at multiple time points (up to 30 hours) post-dose</time_frame>
        <population>The PK analysis set consisted of all participants who received the active study drug and had at least one measurable plasma concentration of TAK-951.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, Treatment A: TAK-951 20 mcg</title>
            <description>TAK-951 20 mcg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, Treatment B: TAK-951 1.0 mg</title>
            <description>TAK-951 1.0 mg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, Treatment C: TAK-951 1.0 mg</title>
            <description>TAK-951 1.0 mg, infusion, intravenously over 120 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4, Treatment D: TAK-951 1.0 mg</title>
            <description>TAK-951 1.0 mg, infusion, intravenously over 180 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
        </group_list>
        <measure>
          <title>λz: Terminal Disposition Phase Rate Constant for TAK-951</title>
          <population>The PK analysis set consisted of all participants who received the active study drug and had at least one measurable plasma concentration of TAK-951.</population>
          <units>per hour (1/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_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1781" spread="0.040265"/>
                    <measurement group_id="O2" value="0.1501" spread="0.016879"/>
                    <measurement group_id="O3" value="0.1574" spread="0.018543"/>
                    <measurement group_id="O4" value="0.1500" spread="0.010488"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Positive Anti-drug Antibodies (ADA) in Serum</title>
        <description>ADA positive was defined as a sample that was evaluated as positive in both the ADA screening and confirmatory assays. ADA positive participants was defined as participants who had at least 1 positive ADA result.</description>
        <time_frame>Baseline up to Day 29</time_frame>
        <population>The immunogenicity analysis set included those participants from the safety analysis set who had a baseline and at least 1 post-dose immunogenicity sample assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohorts 1 to 2, Treatment P1: Placebo Pooled</title>
            <description>TAK-951 placebo-matching (0.2 ml normal saline), infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 3, Treatment P2: Placebo</title>
            <description>TAK-951 placebo-matching (1 ml normal saline), infusion, intravenously over 120 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 4, Treatment P3: Placebo</title>
            <description>TAK-951 placebo-matching (1 ml normal saline), infusion, intravenously over 180 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 1, Treatment A: TAK-951 20 mcg</title>
            <description>TAK-951 20 mcg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
          <group group_id="O5">
            <title>Cohort 2, Treatment B: TAK-951 1.0 mg</title>
            <description>TAK-951 1.0 mg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
          <group group_id="O6">
            <title>Cohort 3, Treatment C: TAK-951 1.0 mg</title>
            <description>TAK-951 1.0 mg, infusion, intravenously over 120 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
          <group group_id="O7">
            <title>Cohort 4, Treatment D: TAK-951 1.0 mg</title>
            <description>TAK-951 1.0 mg, infusion, intravenously over 180 minutes in fasted condition once on Day 1 in healthy participants.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Positive Anti-drug Antibodies (ADA) in Serum</title>
          <description>ADA positive was defined as a sample that was evaluated as positive in both the ADA screening and confirmatory assays. ADA positive participants was defined as participants who had at least 1 positive ADA result.</description>
          <population>The immunogenicity analysis set included those participants from the safety analysis set who had a baseline and at least 1 post-dose immunogenicity sample assessment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="2"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29</time_frame>
      <desc>At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.</desc>
      <group_list>
        <group group_id="E1">
          <title>Cohorts 1 to 2, Treatment P1: Placebo Pooled</title>
          <description>TAK-951 placebo-matching (0.2 ml normal saline), infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.</description>
        </group>
        <group group_id="E2">
          <title>Cohort 3, Treatment P2: Placebo</title>
          <description>TAK-951 placebo-matching (1 ml normal saline), infusion, intravenously over 120 minutes in fasted condition once on Day 1 in healthy participants.</description>
        </group>
        <group group_id="E3">
          <title>Cohort 4, Treatment P3: Placebo</title>
          <description>TAK-951 placebo-matching (1 ml normal saline), infusion, intravenously over 180 minutes in fasted condition once on Day 1 in healthy participants.</description>
        </group>
        <group group_id="E4">
          <title>Cohort 1, Treatment A: TAK-951 20 mcg</title>
          <description>TAK-951 20 mcg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.</description>
        </group>
        <group group_id="E5">
          <title>Cohort 2, Treatment B: TAK-951 1.0 mg</title>
          <description>TAK-951 1.0 mg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.</description>
        </group>
        <group group_id="E6">
          <title>Cohort 3, Treatment C: TAK-951 1.0 mg</title>
          <description>TAK-951 1.0 mg, infusion, intravenously over 120 minutes in fasted condition once on Day 1 in healthy participants.</description>
        </group>
        <group group_id="E7">
          <title>Cohort 4, Treatment D: TAK-951 1.0 mg</title>
          <description>TAK-951 1.0 mg, infusion, intravenously over 180 minutes in fasted condition once on Day 1 in healthy participants.</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="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <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="6"/>
                <counts group_id="E7" 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="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <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="6"/>
                <counts group_id="E7" 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 23</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="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="1" 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="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="1" 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="6"/>
                <counts group_id="E7" subjects_affected="0" 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="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="2"/>
                <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="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Vessel puncture site bruise</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="1" 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="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Vessel puncture site pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="1" 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="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Heart rate increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <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="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Orthostatic heart rate response increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <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="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <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="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <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="6"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Joint swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <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="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <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="6"/>
                <counts group_id="E7" 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="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <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="1" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="1" 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="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="1" 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="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Respiratory tract congestion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="1" 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="6"/>
                <counts group_id="E7" 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>
      <restrictive_agreement>Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>Takeda</organization>
      <phone>+1-877-825-3327</phone>
      <email>TrialDisclosures@takeda.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/NCT04486950
org study id: TAK-951-1004
secondary id: U1111-1251-9214
nct id: NCT04486950
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
It is hoped that a medicine called TAK-951 will eventually be used to treat nausea and
      vomiting. Before then, the sponsor needs to understand how the body processes TAK-951 in
      healthy adults.

      The main aims of this study are as follows:

        -  To check for side effects from TAK-951 when given at a slow and fast infusion rate.

        -  To learn how much TAK-951 participants can receive without getting side effects from it.

      Participants will receive a single infusion of either TAK-951 or placebo. In this study, a
      placebo looks like TAK-951 but does not have any medicine in it. Participants will receive
      either a low dose or high dose of TAK-951. The infusion will take from 1-3 hours.

      Participants will stay in the study clinic for about 4 days to receive the study medicine
      (TAK-951 or placebo) and check for side effects. They will have follow-up visits at the
      clinic about 2 weeks and 4 weeks after treatment.
The drug being tested in this study is called TAK-951. The study will evaluate the safety,
      tolerability and PK of TAK-951 in healthy participants.

      The study will enroll approximately 40 healthy participants. Each cohort will have 8
      participants to be randomized and a minimum of 3 cohorts will be evaluated. Participants will
      be randomly assigned (by chance, like flipping a coin) to receive TAK-951 or placebo in a 6:2
      ratio in one of the following 3 cohorts, which will remain undisclosed to the participant and
      study doctor during the study (unless there is an urgent medical need):

        -  Cohort 1 (Low Dose): TAK-951 20 mcg Infusion Over 60 Minutes

        -  Cohort 2 (High Dose): TAK-951 1 mg Infusion Over 60 Minutes

        -  Cohort 3: TAK-951 1 mg Infusion over 120 Minutes

      Sentinel dosing will be done in first 2 participants in each cohort. The dosing in rest of
      the cohort will done if there are no significant safety or tolerability concerns. Additional
      2 cohorts, each cohort with 8 participants may be added in study to evaluate additional
      intravenous dosing regimen after clinical data analysis of first 3 cohorts. Dosing of the
      subsequent cohort will be based on the analysis of the previous cohort's data.

      This single-center trial will be conducted in the United States. The overall time to
      participate in this study is up to 57 days. All participants will return to clinic after 14
      and 28 days after the last visit to the clinic for a follow-up assessment.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of Participants Who Reported One or More Treatment-emergent Adverse Events (TEAEs)
time frame: Baseline up to Day 29
measure: Number of Participants With Clinically Significant Change From Baseline in Vital Sign Values
time frame: Baseline up to Day 2
measure: Number of Participants With Clinically Significant Change From Baseline in 12- Lead Electrocardiogram (ECG) Values
time frame: Baseline up to Day 2
measure: Number of Participants With Clinically Significant Change From Baseline in Laboratory Values
time frame: Baseline up to Day 2
measure: Number of Participants With Clinically Significant Change From Baseline in Physical Examination Values
time frame: Baseline up to Day 29
measure: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-951
time frame: Day 1 pre-dose and at multiple time points (up to 30 hours) post-dose
measure: Ceoi: Plasma Concentration at the End of Infusion for TAK-951
time frame: Day 1: at the end of infusion (at 30 hours post-infusion)
measure: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-951
time frame: Day 1 pre-dose and at multiple time points (up to 30 hours) post-dose
measure: T1/2z: Terminal Disposition Phase Half-life for TAK-951
time frame: Day 1 pre-dose and at multiple time points (up to 30 hours) post-dose
measure: λz: Terminal Disposition Phase Rate Constant for TAK-951
time frame: Day 1 pre-dose and at multiple time points (up to 30 hours) post-dose
measure: Number of Participants With Positive Anti-drug Antibodies (ADA) in Serum
time frame: Baseline up to Day 29
description: ADA positive was defined as a sample that was evaluated as positive in both the ADA screening and confirmatory assays. ADA positive participants was defined as participants who had at least 1 positive ADA result.
arm group label: Cohort 1 (Low Dose): TAK-951 20 mcg Infusion Over 60 Minutes
arm group type: Experimental
description: TAK-951 20 microgram (mcg) or TAK-951 placebo-matching, infusion, intravenously, over a period of 60 minutes on Day 1.
arm group label: Cohort 2 (High Dose): TAK-951 1 mg Infusion Over 60 Minutes
arm group type: Experimental
description: TAK-951 1 milligram (mg) or TAK-951 placebo-matching, infusion, intravenously, over a period of 60 minutes on Day 1. Dose level will be determined based on safety, tolerability and PK data from previous cohorts.
arm group label: Cohort 3: TAK-951 1 mg Infusion Over 120 Minutes
arm group type: Experimental
description: TAK-951 1 mg or TAK-951 placebo-matching, infusion, intravenously, over a period of 120 minutes on Day 1. Dose level will be determined based on safety, tolerability and PK data from previous cohorts.
intervention type: Drug
intervention name: TAK-951
description: TAK-951 intravenous infusion.
arm group label: Cohort 1 (Low Dose): TAK-951 20 mcg Infusion Over 60 Minutes
arm group label: Cohort 2 (High Dose): TAK-951 1 mg Infusion Over 60 Minutes
arm group label: Cohort 3: TAK-951 1 mg Infusion Over 120 Minutes
intervention type: Drug
intervention name: TAK-951 Placebo
description: TAK-951 placebo-matching intravenous infusion.
arm group label: Cohort 1 (Low Dose): TAK-951 20 mcg Infusion Over 60 Minutes
arm group label: Cohort 2 (High Dose): TAK-951 1 mg Infusion Over 60 Minutes
arm group label: Cohort 3: TAK-951 1 mg Infusion Over 120 Minutes
criteria: 
gender: All
minimum age: 19 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Study Director
role: Study Director
affiliation: Takeda
facility: 
country: United States
url: https://clinicaltrials.takeda.com/study-detail/5f6b603d4db2bf003ab4a3c0
description: To obtain more information on the study, click here/on this link
responsible party type: Sponsor
sharing ipd: Yes
ipd description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
ipd url: https://vivli.org/ourmember/takeda/
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 