<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/NCT03748979</url>
  </required_header>
  <id_info>
    <org_study_id>TAK-925-1003</org_study_id>
    <secondary_id>U1111-1221-3144</secondary_id>
    <secondary_id>JapicCTI-184207</secondary_id>
    <nct_id>NCT03748979</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAK-925 in Healthy Volunteers and Participants With Narcolepsy</brief_title>
  <official_title>A 3-Part, Randomized, Double-Blind, Placebo-Controlled, Multiple Rising Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAK-925 in Healthy Volunteers and Patients With Narcolepsy</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>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the safety, tolerability, pharmacokinetics, and&#xD;
      pharmacodynamics of TAK-925 when administered to healthy participants and narcolepsy&#xD;
      participants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The drug being tested in this study is called TAK-925. TAK-925 is being tested in healthy&#xD;
      participants and participants with narcolepsy. This study will look at the safety,&#xD;
      tolerability, pharmacokinetics, and efficacy of TAK-925.&#xD;
&#xD;
      This study will consist of three parts. Part A will be a randomized, double-blind,&#xD;
      placebo-controlled, multiple rising dose (MRD) study in healthy participants. Part B is a&#xD;
      randomized, double-blind, placebo-controlled MRD study in participants with narcolepsy. Part&#xD;
      C is a randomized, double-blind, placebo-controlled, parallel group, multiple repeat dose&#xD;
      study in participants with narcolepsy. Part A' is a single dose study in healthy&#xD;
      participants.&#xD;
&#xD;
      The study will enroll approximately 96 participants planned as total. All participants except&#xD;
      Part A' will be randomly assigned (by chance, like flipping a coin) to one of the two&#xD;
      treatment groups-which will remain undisclosed to the participants and study doctor during&#xD;
      the study (unless there is an urgent medical need):&#xD;
&#xD;
      Part A:&#xD;
&#xD;
        -  TAK-925 (Dose Levels A1-A6)&#xD;
&#xD;
        -  Placebo&#xD;
&#xD;
      Part B:&#xD;
&#xD;
        -  TAK-925 (Dose Levels B1-B4)&#xD;
&#xD;
        -  Placebo&#xD;
&#xD;
      Part C:&#xD;
&#xD;
        -  TAK-925 (Dose Levels C1-C2)&#xD;
&#xD;
        -  Placebo&#xD;
&#xD;
      Part A':&#xD;
&#xD;
      • TAK-925 (Dose Levels A'1-A'2)&#xD;
&#xD;
      All participants will be asked to take TAK-925 or Placebo at the same time each day from Day&#xD;
      1 to Day 7 in Parts A, B and C, and take TAK-925 on Day 1 in Part A'.&#xD;
&#xD;
      This multi-center trial will be conducted in Japan. The overall study period is approximately&#xD;
      15 days in Parts A, B and C, and approximately 7 days for Part A'. Participants will be&#xD;
      partly admitted to a hospital during the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 21, 2018</start_date>
  <completion_date type="Actual">October 24, 2019</completion_date>
  <primary_completion_date type="Actual">October 24, 2019</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)</measure>
    <time_frame>From the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15)</time_frame>
    <description>An Adverse Event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE was defined as an AE with an onset that occurs after receiving study drug.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Parts A, B and C; Ceoi: Observed Plasma Concentration at the End of Infusion for TAK-925</measure>
    <time_frame>Part A,Days 1,7:pre-infusion(inf),0.5,1, 1.5, 2, 4, 6, 8, 9 hours(h)post start of inf;0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 6, 10, 15 h post end of inf;Part B,C:Days 1,7:Pre-inf, 1, 2, 4, 6, 9 h post start of inf; 0.17, 0.5, 2, 6, 10, 15 h post end of inf</time_frame>
    <description>This assessment was pre-specified to be conducted for participants in &quot;Part A', Cohort A'1: TAK-925 112 mg&quot; as exploratory measures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parts A, B and C; AUCtau: Area Under the Plasma Concentration-Time Curve During a Dosing Interval for TAK-925</measure>
    <time_frame>Part A,Days 1,7:pre-infusion(inf),0.5,1, 1.5, 2, 4, 6, 8, 9 hours(h)post start of inf;0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 6, 10, 15 h post end of inf;Part B,C:Days 1,7:Pre-inf, 1, 2, 4, 6, 9 h post start of inf; 0.17, 0.5, 2, 6, 10, 15 h post end of inf</time_frame>
    <description>This assessment was pre-specified to be conducted for participants in &quot;Part A', Cohort A'1: TAK-925 112 mg&quot; as exploratory measures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parts A, B and C; Rac (AUC): Accumulation Ratio Based on AUCtau for TAK-925</measure>
    <time_frame>Part A,Days 1,7:pre-infusion(inf),0.5,1, 1.5, 2, 4, 6, 8, 9 hours(h)post start of inf;0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 6, 10, 15 h post end of inf;Part B,C:Days 1,7:Pre-inf, 1, 2, 4, 6, 9 h post start of inf; 0.17, 0.5, 2, 6, 10, 15 h post end of inf</time_frame>
    <description>Accumulation Ratio of AUC was calculated as AUCtau on Day 7 divided by AUCtau on Day 1. This assessment was pre-specified to be conducted for participants in &quot;Part A', Cohort A'1: TAK-925 112 mg&quot; as exploratory measures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parts B and C: Change From Baseline in Sleep Latency in the Maintenance of Wakefulness Test (MWT) at Days 1 and 7</measure>
    <time_frame>Baseline, Day 1 and Day 7</time_frame>
    <description>The MWT is a validated objective measure that is used to measure excessive daytime sleepiness in clinical studies. It has been used as a secondary outcome measure for excessive daytime sleepiness. The MWT evaluates a person's ability to remain awake under soporific conditions for a defined period of time. Wakefulness in this study was measured indirectly by time to fall asleep using MWT. In this study, four 40-minute (1 session) MWT assessments per day was administered on Baseline, Day 1 and Day 7. MWT sleep latency ranges from 0 to 40 minutes, with longer sleep latency indicating greater ability to stay awake.</description>
  </secondary_outcome>
  <number_of_arms>17</number_of_arms>
  <enrollment type="Actual">57</enrollment>
  <condition>Healthy Participants</condition>
  <condition>Narcolepsy</condition>
  <arm_group>
    <arm_group_label>Cohort A1; TAK-925 (Dose Level A1)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAK-925, Dose Level A, once daily for up to 7 days in healthy participants.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort A2; TAK-925 (Dose Level A2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAK-925, Dose Level A2, once daily for up to 7 days in healthy participants. Dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort A3; TAK-925 (Dose Level A3)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAK-925, Dose Level A3, once daily for up to 7 days in healthy participants. This group is an additional optional cohort and dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort A4; TAK-925 (Dose Level A4)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAK-925, Dose Level A4, once daily for up to 7 days in healthy participants. This group is an additional optional cohort and dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort A5; TAK-925 (Dose Level A5)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAK-925, Dose Level A5, once daily for up to 7 days in healthy participants. This group is an additional optional cohort and dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort A6; TAK-925 (Dose Level A6)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAK-925, Dose Level A6, once daily for up to 7 days in healthy elderly participants. This group is an additional optional cohort and dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part A (Cohorts A1-A6); TAK-925 Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>TAK-925 Placebo, once daily for up to 7 days in healthy participants.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort B1; TAK-925 (Dose Level B1)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAK-925, Dose Level B1, once daily for up to 7 days in participants with narcolepsy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort B2; TAK-925 (Dose Level B2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAK-925, Dose Level B2, once daily for up to 7 days in participants with narcolepsy. Dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort B3; TAK-925 (Dose Level B3)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAK-925, Dose Level B3, once daily for up to 7 days in participants with narcolepsy. This group is an additional optional cohort and dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort B4; TAK-925 (Dose Level B4)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAK-925, Dose Level B4, once daily for up to 7 days in participants with narcolepsy. This group is an additional optional cohort and dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B (Cohorts B1-B4); TAK-925 Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>TAK-925 Placebo, once daily for up to 7 days in participants with narcolepsy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort C1; TAK-925 (Dose Level C1)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAK-925, Dose Level C1, once daily for up to 7 days in participants with narcolepsy. Dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort C2; TAK-925 (Dose Level C2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAK-925, Dose Level C2, once daily for up to 7 days in participants with narcolepsy. This group is an additional optional cohort and dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part C (Cohorts C1-C2); TAK-925 Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>TAK-925 Placebo, once daily for up to 7 days in participants with narcolepsy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort A'1; TAK-925 (Dose Level A'1)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAK-925, Dose Level A'1, single dose in healthy participants.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort A'2; TAK-925 (Dose Level A'2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAK-925, Dose Level A'2, single dose in healthy participants. Dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TAK-925</intervention_name>
    <description>TAK-925</description>
    <arm_group_label>Cohort A'1; TAK-925 (Dose Level A'1)</arm_group_label>
    <arm_group_label>Cohort A'2; TAK-925 (Dose Level A'2)</arm_group_label>
    <arm_group_label>Cohort A1; TAK-925 (Dose Level A1)</arm_group_label>
    <arm_group_label>Cohort A2; TAK-925 (Dose Level A2)</arm_group_label>
    <arm_group_label>Cohort A3; TAK-925 (Dose Level A3)</arm_group_label>
    <arm_group_label>Cohort A4; TAK-925 (Dose Level A4)</arm_group_label>
    <arm_group_label>Cohort A5; TAK-925 (Dose Level A5)</arm_group_label>
    <arm_group_label>Cohort A6; TAK-925 (Dose Level A6)</arm_group_label>
    <arm_group_label>Cohort B1; TAK-925 (Dose Level B1)</arm_group_label>
    <arm_group_label>Cohort B2; TAK-925 (Dose Level B2)</arm_group_label>
    <arm_group_label>Cohort B3; TAK-925 (Dose Level B3)</arm_group_label>
    <arm_group_label>Cohort B4; TAK-925 (Dose Level B4)</arm_group_label>
    <arm_group_label>Cohort C1; TAK-925 (Dose Level C1)</arm_group_label>
    <arm_group_label>Cohort C2; TAK-925 (Dose Level C2)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>TAK-925 Placebo</description>
    <arm_group_label>Part A (Cohorts A1-A6); TAK-925 Placebo</arm_group_label>
    <arm_group_label>Part B (Cohorts B1-B4); TAK-925 Placebo</arm_group_label>
    <arm_group_label>Part C (Cohorts C1-C2); TAK-925 Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Healthy adult participants and Healthy elderly participants:&#xD;
&#xD;
        • Participant weighs at least 50 kg (Healthy adults participants) / 40 kilogram (kg)&#xD;
        (Healthy elderly participants) and has a body mass index (BMI) from 18.5 to 30 kilogram per&#xD;
        square meter (kg/m^2), inclusive at Screening.&#xD;
&#xD;
        Narcolepsy participants:&#xD;
&#xD;
          -  Participants weighs at least 40 kg inclusive at Screening (&gt;=50 kg is required for&#xD;
             Cohort B4).&#xD;
&#xD;
          -  A diagnosis of narcolepsy, as defined by the International Classification of Sleep&#xD;
             Disorders, Third Edition (ICSD-3).&#xD;
&#xD;
          -  At Day -1, Epworth sleepiness scale (ESS) score &gt;=10&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        All Participants:&#xD;
&#xD;
          -  Participants consume excessive amounts, defined as greater than 6 servings (1 serving&#xD;
             is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy&#xD;
             drinks, or other caffeinated beverages per day.&#xD;
&#xD;
          -  Participants have a moderate to severe substance use disorder.&#xD;
&#xD;
          -  Participants have a risk of suicide according to endorsement of item 4 or 5 with&#xD;
             Screening/Baseline visit C-SSRS (Columbia Suicide Severity Rating Scale) or has made a&#xD;
             suicide attempt in the previous 6 months.&#xD;
&#xD;
          -  Participants have a lifetime history of major psychiatric disorder, such as bipolar&#xD;
             disorder or schizophrenia.&#xD;
&#xD;
          -  Participants experienced sleep wake cycle disturbance with external factors such as&#xD;
             irregular work hours.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Takeda</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sumida Hospital</name>
      <address>
        <city>Sumida-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hakata Clinic</name>
      <address>
        <city>Fukuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PS Clinic</name>
      <address>
        <city>Fukuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>November 15, 2018</study_first_submitted>
  <study_first_submitted_qc>November 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <results_first_submitted>October 23, 2020</results_first_submitted>
  <results_first_submitted_qc>December 3, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">December 8, 2020</results_first_posted>
  <last_update_submitted>December 3, 2020</last_update_submitted>
  <last_update_submitted_qc>December 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Narcolepsy</mesh_term>
  </condition_browse>
  <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>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>October 28, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/79/NCT03748979/SAP_000.pdf</document_url>
    </provided_document>
    <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>June 12, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/79/NCT03748979/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants took part in the study at 3 investigative sites in Japan from 21 November 2018 to 24 October 2019.</recruitment_details>
      <pre_assignment_details>Healthy participants were enrolled in Part A and A' (exploratory), NT1 in Part B and NT2 in Part C, to receive TAK-925 multiple rising dose of 44 mg (milligram), 112 mg,180 mg or placebo in Part A, 11 mg, 44 mg or placebo in Part B, multiple dose of TAK-925 44 mg, 112 mg or placebo in Part C.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Part A, Cohorts A1-A3: Pooled Placebo</title>
          <description>TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.</description>
        </group>
        <group group_id="P2">
          <title>Part A, Cohort A1: TAK-925 44 mg</title>
          <description>TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.</description>
        </group>
        <group group_id="P3">
          <title>Part A, Cohort A2: TAK-925 112 mg</title>
          <description>TAK-925 112 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.</description>
        </group>
        <group group_id="P4">
          <title>Part A, Cohort A3: TAK-925 180 mg</title>
          <description>TAK-925 180 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.</description>
        </group>
        <group group_id="P5">
          <title>Part B, Cohorts B1-B2: Pooled Placebo</title>
          <description>TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in narcolepsy type 1 (NT1) participants.</description>
        </group>
        <group group_id="P6">
          <title>Part B, Cohort B1: TAK-925 11 mg</title>
          <description>TAK-925 11 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.</description>
        </group>
        <group group_id="P7">
          <title>Part B, Cohort B2: TAK-925 44 mg</title>
          <description>TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.</description>
        </group>
        <group group_id="P8">
          <title>Part C, Cohorts C1-C2: Pooled Placebo</title>
          <description>TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in narcolepsy type 2 (NT2) participants.</description>
        </group>
        <group group_id="P9">
          <title>Part C, Cohort C1: TAK-925 44 mg</title>
          <description>TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.</description>
        </group>
        <group group_id="P10">
          <title>Part C, Cohort C2: TAK-925 112 mg</title>
          <description>TAK-925 112 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.</description>
        </group>
        <group group_id="P11">
          <title>Part A', Cohort A'1: TAK-925 112 mg</title>
          <description>TAK-925 112 mg, solution, orally, 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="6"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="4"/>
                <participants group_id="P7" count="5"/>
                <participants group_id="P8" count="5"/>
                <participants group_id="P9" count="4"/>
                <participants group_id="P10" count="5"/>
                <participants group_id="P11" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="4"/>
                <participants group_id="P7" count="5"/>
                <participants group_id="P8" count="5"/>
                <participants group_id="P9" count="4"/>
                <participants group_id="P10" count="5"/>
                <participants group_id="P11" 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="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The safety set was defined as all participants who received at least one dose of study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>Part A, Cohorts A1-A3: Pooled Placebo</title>
          <description>TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.</description>
        </group>
        <group group_id="B2">
          <title>Part A, Cohort A1: TAK-925 44 mg</title>
          <description>TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.</description>
        </group>
        <group group_id="B3">
          <title>Part A, Cohort A2: TAK-925 112 mg</title>
          <description>TAK-925 112 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.</description>
        </group>
        <group group_id="B4">
          <title>Part A, Cohort A3: TAK-925 180 mg</title>
          <description>TAK-925 180 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.</description>
        </group>
        <group group_id="B5">
          <title>Part B, Cohorts B1-B2: Pooled Placebo</title>
          <description>TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.</description>
        </group>
        <group group_id="B6">
          <title>Part B, Cohort B1: TAK-925 11 mg</title>
          <description>TAK-925 11 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.</description>
        </group>
        <group group_id="B7">
          <title>Part B, Cohort B2: TAK-925 44 mg</title>
          <description>TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.</description>
        </group>
        <group group_id="B8">
          <title>Part C, Cohorts C1-C2: Pooled Placebo</title>
          <description>TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.</description>
        </group>
        <group group_id="B9">
          <title>Part C, Cohort C1: TAK-925 44 mg</title>
          <description>TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.</description>
        </group>
        <group group_id="B10">
          <title>Part C, Cohort C2: TAK-925 112 mg</title>
          <description>TAK-925 112 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.</description>
        </group>
        <group group_id="B11">
          <title>Part A', Cohort A'1: TAK-925 112 mg</title>
          <description>TAK-925 112 mg, solution, orally, once on Day 1 in healthy participants.</description>
        </group>
        <group group_id="B12">
          <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="6"/>
            <count group_id="B2" value="6"/>
            <count group_id="B3" value="6"/>
            <count group_id="B4" value="6"/>
            <count group_id="B5" value="4"/>
            <count group_id="B6" value="4"/>
            <count group_id="B7" value="5"/>
            <count group_id="B8" value="5"/>
            <count group_id="B9" value="4"/>
            <count group_id="B10" value="5"/>
            <count group_id="B11" value="6"/>
            <count group_id="B12" value="57"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="6"/>
                    <count group_id="B2" value="6"/>
                    <count group_id="B3" value="6"/>
                    <count group_id="B4" value="6"/>
                    <count group_id="B5" value="4"/>
                    <count group_id="B6" value="4"/>
                    <count group_id="B7" value="5"/>
                    <count group_id="B8" value="5"/>
                    <count group_id="B9" value="4"/>
                    <count group_id="B10" value="5"/>
                    <count group_id="B11" value="6"/>
                    <count group_id="B12" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.8" spread="4.71"/>
                    <measurement group_id="B2" value="24.7" spread="3.88"/>
                    <measurement group_id="B3" value="23.8" spread="3.54"/>
                    <measurement group_id="B4" value="22.3" spread="0.52"/>
                    <measurement group_id="B5" value="28.3" spread="9.18"/>
                    <measurement group_id="B6" value="38.0" spread="3.92"/>
                    <measurement group_id="B7" value="27.6" spread="8.20"/>
                    <measurement group_id="B8" value="31.8" spread="11.14"/>
                    <measurement group_id="B9" value="31.3" spread="7.50"/>
                    <measurement group_id="B10" value="25.0" spread="5.87"/>
                    <measurement group_id="B11" value="21.7" spread="2.88"/>
                    <measurement group_id="B12" value="26.6" spread="7.04"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="6"/>
                    <count group_id="B2" value="6"/>
                    <count group_id="B3" value="6"/>
                    <count group_id="B4" value="6"/>
                    <count group_id="B5" value="4"/>
                    <count group_id="B6" value="4"/>
                    <count group_id="B7" value="5"/>
                    <count group_id="B8" value="5"/>
                    <count group_id="B9" value="4"/>
                    <count group_id="B10" value="5"/>
                    <count group_id="B11" value="6"/>
                    <count group_id="B12" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="3"/>
                    <measurement group_id="B9" value="3"/>
                    <measurement group_id="B10" value="2"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="3"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="1"/>
                    <measurement group_id="B10" value="3"/>
                    <measurement group_id="B11" value="6"/>
                    <measurement group_id="B12" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="0"/>
                    <count group_id="B5" value="0"/>
                    <count group_id="B6" value="0"/>
                    <count group_id="B7" value="0"/>
                    <count group_id="B8" value="0"/>
                    <count group_id="B9" value="0"/>
                    <count group_id="B10" value="0"/>
                    <count group_id="B11" value="0"/>
                    <count group_id="B12" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B12" 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>Japan</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="6"/>
                    <count group_id="B2" value="6"/>
                    <count group_id="B3" value="6"/>
                    <count group_id="B4" value="6"/>
                    <count group_id="B5" value="4"/>
                    <count group_id="B6" value="4"/>
                    <count group_id="B7" value="5"/>
                    <count group_id="B8" value="5"/>
                    <count group_id="B9" value="4"/>
                    <count group_id="B10" value="5"/>
                    <count group_id="B11" value="6"/>
                    <count group_id="B12" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="4"/>
                    <measurement group_id="B7" value="5"/>
                    <measurement group_id="B8" value="5"/>
                    <measurement group_id="B9" value="4"/>
                    <measurement group_id="B10" value="5"/>
                    <measurement group_id="B11" value="6"/>
                    <measurement group_id="B12" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <units>kilogram per square meter (kg/m˄2)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="6"/>
                    <count group_id="B2" value="6"/>
                    <count group_id="B3" value="6"/>
                    <count group_id="B4" value="6"/>
                    <count group_id="B5" value="4"/>
                    <count group_id="B6" value="4"/>
                    <count group_id="B7" value="5"/>
                    <count group_id="B8" value="5"/>
                    <count group_id="B9" value="4"/>
                    <count group_id="B10" value="5"/>
                    <count group_id="B11" value="6"/>
                    <count group_id="B12" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22.42" spread="0.968"/>
                    <measurement group_id="B2" value="21.12" spread="1.030"/>
                    <measurement group_id="B3" value="22.37" spread="1.960"/>
                    <measurement group_id="B4" value="21.87" spread="2.360"/>
                    <measurement group_id="B5" value="24.83" spread="2.378"/>
                    <measurement group_id="B6" value="27.33" spread="4.955"/>
                    <measurement group_id="B7" value="24.68" spread="4.791"/>
                    <measurement group_id="B8" value="20.88" spread="3.565"/>
                    <measurement group_id="B9" value="22.83" spread="4.213"/>
                    <measurement group_id="B10" value="22.18" spread="3.489"/>
                    <measurement group_id="B11" value="21.05" spread="1.174"/>
                    <measurement group_id="B12" value="22.66" spread="3.210"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>centimeter (cm)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="6"/>
                    <count group_id="B2" value="6"/>
                    <count group_id="B3" value="6"/>
                    <count group_id="B4" value="6"/>
                    <count group_id="B5" value="4"/>
                    <count group_id="B6" value="4"/>
                    <count group_id="B7" value="5"/>
                    <count group_id="B8" value="5"/>
                    <count group_id="B9" value="4"/>
                    <count group_id="B10" value="5"/>
                    <count group_id="B11" value="6"/>
                    <count group_id="B12" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="170.2" spread="4.71"/>
                    <measurement group_id="B2" value="173.3" spread="4.84"/>
                    <measurement group_id="B3" value="168.8" spread="5.85"/>
                    <measurement group_id="B4" value="170.8" spread="4.71"/>
                    <measurement group_id="B5" value="169.8" spread="7.80"/>
                    <measurement group_id="B6" value="165.3" spread="8.18"/>
                    <measurement group_id="B7" value="166.8" spread="7.56"/>
                    <measurement group_id="B8" value="162.2" spread="5.02"/>
                    <measurement group_id="B9" value="158.0" spread="5.60"/>
                    <measurement group_id="B10" value="164.6" spread="5.46"/>
                    <measurement group_id="B11" value="170.7" spread="3.44"/>
                    <measurement group_id="B12" value="167.8" spread="6.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kilogram (kg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="6"/>
                    <count group_id="B2" value="6"/>
                    <count group_id="B3" value="6"/>
                    <count group_id="B4" value="6"/>
                    <count group_id="B5" value="4"/>
                    <count group_id="B6" value="4"/>
                    <count group_id="B7" value="5"/>
                    <count group_id="B8" value="5"/>
                    <count group_id="B9" value="4"/>
                    <count group_id="B10" value="5"/>
                    <count group_id="B11" value="6"/>
                    <count group_id="B12" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64.58" spread="5.486"/>
                    <measurement group_id="B2" value="62.75" spread="3.250"/>
                    <measurement group_id="B3" value="63.72" spread="7.392"/>
                    <measurement group_id="B4" value="63.60" spread="7.987"/>
                    <measurement group_id="B5" value="72.90" spread="13.071"/>
                    <measurement group_id="B6" value="75.20" spread="18.150"/>
                    <measurement group_id="B7" value="70.32" spread="15.554"/>
                    <measurement group_id="B8" value="56.20" spread="11.689"/>
                    <measurement group_id="B9" value="57.73" spread="13.072"/>
                    <measurement group_id="B10" value="61.68" spread="10.055"/>
                    <measurement group_id="B11" value="60.60" spread="4.549"/>
                    <measurement group_id="B12" value="64.14" spread="10.706"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)</title>
        <description>An Adverse Event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE was defined as an AE with an onset that occurs after receiving study drug.</description>
        <time_frame>From the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15)</time_frame>
        <population>The safety set was defined as all participants who received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A, Cohorts A1-A3: Pooled Placebo</title>
            <description>TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.</description>
          </group>
          <group group_id="O2">
            <title>Part A, Cohort A1: TAK-925 44 mg</title>
            <description>TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.</description>
          </group>
          <group group_id="O3">
            <title>Part A, Cohort A2: TAK-925 112 mg</title>
            <description>TAK-925 112 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.</description>
          </group>
          <group group_id="O4">
            <title>Part A, Cohort A3: TAK-925 180 mg</title>
            <description>TAK-925 180 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.</description>
          </group>
          <group group_id="O5">
            <title>Part B, Cohorts B1-B2: Pooled Placebo</title>
            <description>TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.</description>
          </group>
          <group group_id="O6">
            <title>Part B, Cohort B1: TAK-925 11 mg</title>
            <description>TAK-925 11 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.</description>
          </group>
          <group group_id="O7">
            <title>Part B, Cohort B2: TAK-925 44 mg</title>
            <description>TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.</description>
          </group>
          <group group_id="O8">
            <title>Part C, Cohorts C1-C2: Pooled Placebo</title>
            <description>TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.</description>
          </group>
          <group group_id="O9">
            <title>Part C, Cohort C1: TAK-925 44 mg</title>
            <description>TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.</description>
          </group>
          <group group_id="O10">
            <title>Part C, Cohort C2: TAK-925 112 mg</title>
            <description>TAK-925 112 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.</description>
          </group>
          <group group_id="O11">
            <title>Part A', Cohort A'1: TAK-925 112 mg</title>
            <description>TAK-925 112 mg, solution, orally, once on Day 1 in healthy participants.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)</title>
          <description>An Adverse Event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE was defined as an AE with an onset that occurs after receiving study drug.</description>
          <population>The safety set was defined as all participants who received at least one dose of study drug.</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="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="4"/>
                <count group_id="O6" value="4"/>
                <count group_id="O7" value="5"/>
                <count group_id="O8" value="5"/>
                <count group_id="O9" value="4"/>
                <count group_id="O10" value="5"/>
                <count group_id="O11" 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="2"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="5"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="1"/>
                    <measurement group_id="O10" value="3"/>
                    <measurement group_id="O11" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Parts A, B and C; Ceoi: Observed Plasma Concentration at the End of Infusion for TAK-925</title>
        <description>This assessment was pre-specified to be conducted for participants in &quot;Part A', Cohort A'1: TAK-925 112 mg&quot; as exploratory measures.</description>
        <time_frame>Part A,Days 1,7:pre-infusion(inf),0.5,1, 1.5, 2, 4, 6, 8, 9 hours(h)post start of inf;0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 6, 10, 15 h post end of inf;Part B,C:Days 1,7:Pre-inf, 1, 2, 4, 6, 9 h post start of inf; 0.17, 0.5, 2, 6, 10, 15 h post end of inf</time_frame>
        <population>The pharmacokinetic (PK) set was defined as all participants who received at least one dose of study drug and provided sufficient PK measurements available to estimate PK parameters, at least 1 estimable PK parameter.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A, Cohort A1: TAK-925 44 mg</title>
            <description>TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.</description>
          </group>
          <group group_id="O2">
            <title>Part A, Cohort A2: TAK-925 112 mg</title>
            <description>TAK-925 112 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.</description>
          </group>
          <group group_id="O3">
            <title>Part A, Cohort A3: TAK-925 180 mg</title>
            <description>TAK-925 180 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.</description>
          </group>
          <group group_id="O4">
            <title>Part B, Cohort B1: TAK-925 11 mg</title>
            <description>TAK-925 11 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.</description>
          </group>
          <group group_id="O5">
            <title>Part B, Cohort B2: TAK-925 44 mg</title>
            <description>TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.</description>
          </group>
          <group group_id="O6">
            <title>Part C, Cohort C1: TAK-925 44 mg</title>
            <description>TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.</description>
          </group>
          <group group_id="O7">
            <title>Part C, Cohort C2: TAK-925 112 mg</title>
            <description>TAK-925 112 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.</description>
          </group>
        </group_list>
        <measure>
          <title>Parts A, B and C; Ceoi: Observed Plasma Concentration at the End of Infusion for TAK-925</title>
          <description>This assessment was pre-specified to be conducted for participants in &quot;Part A', Cohort A'1: TAK-925 112 mg&quot; as exploratory measures.</description>
          <population>The pharmacokinetic (PK) set was defined as all participants who received at least one dose of study drug and provided sufficient PK measurements available to estimate PK parameters, at least 1 estimable PK parameter.</population>
          <units>nanogram per milliliter (ng/mL)</units>
          <param>Geometric 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="4"/>
                <count group_id="O5" value="5"/>
                <count group_id="O6" value="4"/>
                <count group_id="O7" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.49" spread="4.3433"/>
                    <measurement group_id="O2" value="166.9" spread="20.995"/>
                    <measurement group_id="O3" value="300.2" spread="50.532"/>
                    <measurement group_id="O4" value="17.39" spread="1.2842"/>
                    <measurement group_id="O5" value="70.20" spread="18.798"/>
                    <measurement group_id="O6" value="68.74" spread="7.3623"/>
                    <measurement group_id="O7" value="156.1" spread="29.210"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.31" spread="8.4434"/>
                    <measurement group_id="O2" value="159.2" spread="23.560"/>
                    <measurement group_id="O3" value="295.5" spread="46.173"/>
                    <measurement group_id="O4" value="17.68" spread="1.7176"/>
                    <measurement group_id="O5" value="73.20" spread="14.980"/>
                    <measurement group_id="O6" value="70.87" spread="7.4375"/>
                    <measurement group_id="O7" value="153.9" spread="24.876"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Parts A, B and C; AUCtau: Area Under the Plasma Concentration-Time Curve During a Dosing Interval for TAK-925</title>
        <description>This assessment was pre-specified to be conducted for participants in &quot;Part A', Cohort A'1: TAK-925 112 mg&quot; as exploratory measures.</description>
        <time_frame>Part A,Days 1,7:pre-infusion(inf),0.5,1, 1.5, 2, 4, 6, 8, 9 hours(h)post start of inf;0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 6, 10, 15 h post end of inf;Part B,C:Days 1,7:Pre-inf, 1, 2, 4, 6, 9 h post start of inf; 0.17, 0.5, 2, 6, 10, 15 h post end of inf</time_frame>
        <population>The PK set was defined as all participants who received at least one dose of study drug and provided sufficient PK measurements available to estimate PK parameters, at least 1 estimable PK parameter.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A, Cohort A1: TAK-925 44 mg</title>
            <description>TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.</description>
          </group>
          <group group_id="O2">
            <title>Part A, Cohort A2: TAK-925 112 mg</title>
            <description>TAK-925 112 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.</description>
          </group>
          <group group_id="O3">
            <title>Part A, Cohort A3: TAK-925 180 mg</title>
            <description>TAK-925 180 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.</description>
          </group>
          <group group_id="O4">
            <title>Part B, Cohort B1: TAK-925 11 mg</title>
            <description>TAK-925 11 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.</description>
          </group>
          <group group_id="O5">
            <title>Part B, Cohort B2: TAK-925 44 mg</title>
            <description>TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.</description>
          </group>
          <group group_id="O6">
            <title>Part C, Cohort C1: TAK-925 44 mg</title>
            <description>TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.</description>
          </group>
          <group group_id="O7">
            <title>Part C, Cohort C2: TAK-925 112 mg</title>
            <description>TAK-925 112 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.</description>
          </group>
        </group_list>
        <measure>
          <title>Parts A, B and C; AUCtau: Area Under the Plasma Concentration-Time Curve During a Dosing Interval for TAK-925</title>
          <description>This assessment was pre-specified to be conducted for participants in &quot;Part A', Cohort A'1: TAK-925 112 mg&quot; as exploratory measures.</description>
          <population>The PK set was defined as all participants who received at least one dose of study drug and provided sufficient PK measurements available to estimate PK parameters, at least 1 estimable PK parameter.</population>
          <units>hour*nanogram per milliliter (h*ng/mL)</units>
          <param>Geometric 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="4"/>
                <count group_id="O5" value="5"/>
                <count group_id="O6" value="4"/>
                <count group_id="O7" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="662.4" spread="70.718"/>
                    <measurement group_id="O2" value="1516" spread="151.45"/>
                    <measurement group_id="O3" value="2615" spread="392.89"/>
                    <measurement group_id="O4" value="164.2" spread="18.257"/>
                    <measurement group_id="O5" value="682.3" spread="126.81"/>
                    <measurement group_id="O6" value="648.3" spread="80.748"/>
                    <measurement group_id="O7" value="1496" spread="279.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="650.7" spread="78.156"/>
                    <measurement group_id="O2" value="1523" spread="174.40"/>
                    <measurement group_id="O3" value="2747" spread="372.96"/>
                    <measurement group_id="O4" value="182.7" spread="22.603"/>
                    <measurement group_id="O5" value="722.7" spread="102.28"/>
                    <measurement group_id="O6" value="657.1" spread="72.833"/>
                    <measurement group_id="O7" value="1519" spread="248.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Parts A, B and C; Rac (AUC): Accumulation Ratio Based on AUCtau for TAK-925</title>
        <description>Accumulation Ratio of AUC was calculated as AUCtau on Day 7 divided by AUCtau on Day 1. This assessment was pre-specified to be conducted for participants in &quot;Part A', Cohort A'1: TAK-925 112 mg&quot; as exploratory measures.</description>
        <time_frame>Part A,Days 1,7:pre-infusion(inf),0.5,1, 1.5, 2, 4, 6, 8, 9 hours(h)post start of inf;0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 6, 10, 15 h post end of inf;Part B,C:Days 1,7:Pre-inf, 1, 2, 4, 6, 9 h post start of inf; 0.17, 0.5, 2, 6, 10, 15 h post end of inf</time_frame>
        <population>The PK set was defined as all participants who received at least one dose of study drug and provided sufficient PK measurements available to estimate PK parameters, at least 1 estimable PK parameter.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A, Cohort A1: TAK-925 44 mg</title>
            <description>TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.</description>
          </group>
          <group group_id="O2">
            <title>Part A, Cohort A2: TAK-925 112 mg</title>
            <description>TAK-925 112 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.</description>
          </group>
          <group group_id="O3">
            <title>Part A, Cohort A3: TAK-925 180 mg</title>
            <description>TAK-925 180 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.</description>
          </group>
          <group group_id="O4">
            <title>Part B, Cohort B1: TAK-925 11 mg</title>
            <description>TAK-925 11 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.</description>
          </group>
          <group group_id="O5">
            <title>Part B, Cohort B2: TAK-925 44 mg</title>
            <description>TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.</description>
          </group>
          <group group_id="O6">
            <title>Part C, Cohort C1: TAK-925 44 mg</title>
            <description>TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.</description>
          </group>
          <group group_id="O7">
            <title>Part C, Cohort C2: TAK-925 112 mg</title>
            <description>TAK-925 112 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.</description>
          </group>
        </group_list>
        <measure>
          <title>Parts A, B and C; Rac (AUC): Accumulation Ratio Based on AUCtau for TAK-925</title>
          <description>Accumulation Ratio of AUC was calculated as AUCtau on Day 7 divided by AUCtau on Day 1. This assessment was pre-specified to be conducted for participants in &quot;Part A', Cohort A'1: TAK-925 112 mg&quot; as exploratory measures.</description>
          <population>The PK set was defined as all participants who received at least one dose of study drug and provided sufficient PK measurements available to estimate PK parameters, at least 1 estimable PK parameter.</population>
          <units>ratio</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="4"/>
                <count group_id="O5" value="5"/>
                <count group_id="O6" value="4"/>
                <count group_id="O7" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9832" spread="0.041034"/>
                    <measurement group_id="O2" value="1.009" spread="0.080171"/>
                    <measurement group_id="O3" value="1.050" spread="0.020000"/>
                    <measurement group_id="O4" value="1.118" spread="0.14637"/>
                    <measurement group_id="O5" value="1.062" spread="0.066062"/>
                    <measurement group_id="O6" value="1.017" spread="0.098127"/>
                    <measurement group_id="O7" value="1.018" spread="0.030760"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Parts B and C: Change From Baseline in Sleep Latency in the Maintenance of Wakefulness Test (MWT) at Days 1 and 7</title>
        <description>The MWT is a validated objective measure that is used to measure excessive daytime sleepiness in clinical studies. It has been used as a secondary outcome measure for excessive daytime sleepiness. The MWT evaluates a person's ability to remain awake under soporific conditions for a defined period of time. Wakefulness in this study was measured indirectly by time to fall asleep using MWT. In this study, four 40-minute (1 session) MWT assessments per day was administered on Baseline, Day 1 and Day 7. MWT sleep latency ranges from 0 to 40 minutes, with longer sleep latency indicating greater ability to stay awake.</description>
        <time_frame>Baseline, Day 1 and Day 7</time_frame>
        <population>The pharmacodynamic (PD) set was defined as all participants who received at least one dose of study drug. Here number analyzed &quot;n&quot; are the participants who were evaluable for the outcome measure at given time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Part B, Cohorts B1-B2: Pooled Placebo</title>
            <description>TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.</description>
          </group>
          <group group_id="O2">
            <title>Part B, Cohort B1: TAK-925 11 mg</title>
            <description>TAK-925 11 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.</description>
          </group>
          <group group_id="O3">
            <title>Part B, Cohort B2: TAK-925 44 mg</title>
            <description>TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.</description>
          </group>
          <group group_id="O4">
            <title>Part C, Cohorts C1-C2: Pooled Placebo</title>
            <description>TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.</description>
          </group>
          <group group_id="O5">
            <title>Part C, Cohort C1: TAK-925 44 mg</title>
            <description>TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.</description>
          </group>
          <group group_id="O6">
            <title>Part C, Cohort C2: TAK-925 112 mg</title>
            <description>TAK-925 112 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.</description>
          </group>
        </group_list>
        <measure>
          <title>Parts B and C: Change From Baseline in Sleep Latency in the Maintenance of Wakefulness Test (MWT) at Days 1 and 7</title>
          <description>The MWT is a validated objective measure that is used to measure excessive daytime sleepiness in clinical studies. It has been used as a secondary outcome measure for excessive daytime sleepiness. The MWT evaluates a person's ability to remain awake under soporific conditions for a defined period of time. Wakefulness in this study was measured indirectly by time to fall asleep using MWT. In this study, four 40-minute (1 session) MWT assessments per day was administered on Baseline, Day 1 and Day 7. MWT sleep latency ranges from 0 to 40 minutes, with longer sleep latency indicating greater ability to stay awake.</description>
          <population>The pharmacodynamic (PD) set was defined as all participants who received at least one dose of study drug. Here number analyzed &quot;n&quot; are the participants who were evaluable for the outcome measure at given time points.</population>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="5"/>
                <count group_id="O5" value="4"/>
                <count group_id="O6" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="5"/>
                    <count group_id="O5" value="3"/>
                    <count group_id="O6" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.97" spread="0.850"/>
                    <measurement group_id="O2" value="2.03" spread="0.717"/>
                    <measurement group_id="O3" value="5.23" spread="4.029"/>
                    <measurement group_id="O4" value="4.13" spread="3.280"/>
                    <measurement group_id="O5" value="6.83" spread="3.924"/>
                    <measurement group_id="O6" value="7.33" spread="5.932"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="5"/>
                    <count group_id="O5" value="3"/>
                    <count group_id="O6" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.66" spread="0.892"/>
                    <measurement group_id="O2" value="35.13" spread="4.268"/>
                    <measurement group_id="O3" value="34.19" spread="4.398"/>
                    <measurement group_id="O4" value="2.58" spread="3.751"/>
                    <measurement group_id="O5" value="23.88" spread="2.955"/>
                    <measurement group_id="O6" value="31.15" spread="5.507"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="5"/>
                    <count group_id="O5" value="3"/>
                    <count group_id="O6" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.38" spread="0.621"/>
                    <measurement group_id="O2" value="21.00" spread="12.141"/>
                    <measurement group_id="O3" value="34.78" spread="4.029"/>
                    <measurement group_id="O4" value="2.35" spread="3.369"/>
                    <measurement group_id="O5" value="25.79" spread="7.544"/>
                    <measurement group_id="O6" value="28.28" spread="4.886"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>P-value was obtained using MMRM analysis. The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group on Day 1.</p_value_desc>
            <method>Mixed Model for Repeated Measures (MMRM)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>P-value was obtained using MMRM analysis. The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group on Day 1.</p_value_desc>
            <method>MMRM</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0002</p_value>
            <p_value_desc>P-value was obtained using MMRM analysis. The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group on Day 7.</p_value_desc>
            <method>MMRM</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>P-value was obtained using MMRM analysis. The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group on Day 7.</p_value_desc>
            <method>MMRM</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>P-value was obtained using MMRM analysis. The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group on Day 1.</p_value_desc>
            <method>MMRM</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>P-value was obtained using MMRM analysis. The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group on Day 1.</p_value_desc>
            <method>MMRM</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>P-value was obtained using MMRM analysis. The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group on Day 7.</p_value_desc>
            <method>MMRM</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>P-value was obtained using MMRM analysis. The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group on Day 7.</p_value_desc>
            <method>MMRM</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15)</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>Part A, Cohorts A1-A3: Pooled Placebo</title>
          <description>TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.</description>
        </group>
        <group group_id="E2">
          <title>Part A, Cohort A1: TAK-925 44 mg</title>
          <description>TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.</description>
        </group>
        <group group_id="E3">
          <title>Part A, Cohort A2: TAK-925 112 mg</title>
          <description>TAK-925 112 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.</description>
        </group>
        <group group_id="E4">
          <title>Part A, Cohort A3: TAK-925 180 mg</title>
          <description>TAK-925 180 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.</description>
        </group>
        <group group_id="E5">
          <title>Part B, Cohorts B1-B2: Pooled Placebo</title>
          <description>TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.</description>
        </group>
        <group group_id="E6">
          <title>Part B, Cohort B1: TAK-925 11 mg</title>
          <description>TAK-925 11 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.</description>
        </group>
        <group group_id="E7">
          <title>Part B, Cohort B2: TAK-925 44 mg</title>
          <description>TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.</description>
        </group>
        <group group_id="E8">
          <title>Part C, Cohorts C1-C2: Pooled Placebo</title>
          <description>TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.</description>
        </group>
        <group group_id="E9">
          <title>Part C, Cohort C1: TAK-925 44 mg</title>
          <description>TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.</description>
        </group>
        <group group_id="E10">
          <title>Part C, Cohort C2: TAK-925 112 mg</title>
          <description>TAK-925 112 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.</description>
        </group>
        <group group_id="E11">
          <title>Part A', Cohort A'1: TAK-925 112 mg</title>
          <description>TAK-925 112 mg, solution, orally, 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="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (22.0)</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="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="5" subjects_at_risk="5"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="5"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Salivary hypersecretion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Feeling abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="5"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Dysmenorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <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>Medical 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/NCT03748979
org study id: TAK-925-1003
secondary id: U1111-1221-3144
secondary id: JapicCTI-184207
nct id: NCT03748979
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to investigate the safety, tolerability, pharmacokinetics, and
      pharmacodynamics of TAK-925 when administered to healthy participants and narcolepsy
      participants.
The drug being tested in this study is called TAK-925. TAK-925 is being tested in healthy
      participants and participants with narcolepsy. This study will look at the safety,
      tolerability, pharmacokinetics, and efficacy of TAK-925.

      This study will consist of three parts. Part A will be a randomized, double-blind,
      placebo-controlled, multiple rising dose (MRD) study in healthy participants. Part B is a
      randomized, double-blind, placebo-controlled MRD study in participants with narcolepsy. Part
      C is a randomized, double-blind, placebo-controlled, parallel group, multiple repeat dose
      study in participants with narcolepsy. Part A' is a single dose study in healthy
      participants.

      The study will enroll approximately 96 participants planned as total. All participants except
      Part A' will be randomly assigned (by chance, like flipping a coin) to one of the two
      treatment groups-which will remain undisclosed to the participants and study doctor during
      the study (unless there is an urgent medical need):

      Part A:

        -  TAK-925 (Dose Levels A1-A6)

        -  Placebo

      Part B:

        -  TAK-925 (Dose Levels B1-B4)

        -  Placebo

      Part C:

        -  TAK-925 (Dose Levels C1-C2)

        -  Placebo

      Part A':

      • TAK-925 (Dose Levels A'1-A'2)

      All participants will be asked to take TAK-925 or Placebo at the same time each day from Day
      1 to Day 7 in Parts A, B and C, and take TAK-925 on Day 1 in Part A'.

      This multi-center trial will be conducted in Japan. The overall study period is approximately
      15 days in Parts A, B and C, and approximately 7 days for Part A'. Participants will be
      partly admitted to a hospital during the study.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
time frame: From the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15)
description: An Adverse Event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE was defined as an AE with an onset that occurs after receiving study drug.
measure: Parts A, B and C; Ceoi: Observed Plasma Concentration at the End of Infusion for TAK-925
time frame: Part A,Days 1,7:pre-infusion(inf),0.5,1, 1.5, 2, 4, 6, 8, 9 hours(h)post start of inf;0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 6, 10, 15 h post end of inf;Part B,C:Days 1,7:Pre-inf, 1, 2, 4, 6, 9 h post start of inf; 0.17, 0.5, 2, 6, 10, 15 h post end of inf
description: This assessment was pre-specified to be conducted for participants in "Part A', Cohort A'1: TAK-925 112 mg" as exploratory measures.
measure: Parts A, B and C; AUCtau: Area Under the Plasma Concentration-Time Curve During a Dosing Interval for TAK-925
time frame: Part A,Days 1,7:pre-infusion(inf),0.5,1, 1.5, 2, 4, 6, 8, 9 hours(h)post start of inf;0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 6, 10, 15 h post end of inf;Part B,C:Days 1,7:Pre-inf, 1, 2, 4, 6, 9 h post start of inf; 0.17, 0.5, 2, 6, 10, 15 h post end of inf
description: This assessment was pre-specified to be conducted for participants in "Part A', Cohort A'1: TAK-925 112 mg" as exploratory measures.
measure: Parts A, B and C; Rac (AUC): Accumulation Ratio Based on AUCtau for TAK-925
time frame: Part A,Days 1,7:pre-infusion(inf),0.5,1, 1.5, 2, 4, 6, 8, 9 hours(h)post start of inf;0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 6, 10, 15 h post end of inf;Part B,C:Days 1,7:Pre-inf, 1, 2, 4, 6, 9 h post start of inf; 0.17, 0.5, 2, 6, 10, 15 h post end of inf
description: Accumulation Ratio of AUC was calculated as AUCtau on Day 7 divided by AUCtau on Day 1. This assessment was pre-specified to be conducted for participants in "Part A', Cohort A'1: TAK-925 112 mg" as exploratory measures.
measure: Parts B and C: Change From Baseline in Sleep Latency in the Maintenance of Wakefulness Test (MWT) at Days 1 and 7
time frame: Baseline, Day 1 and Day 7
description: The MWT is a validated objective measure that is used to measure excessive daytime sleepiness in clinical studies. It has been used as a secondary outcome measure for excessive daytime sleepiness. The MWT evaluates a person's ability to remain awake under soporific conditions for a defined period of time. Wakefulness in this study was measured indirectly by time to fall asleep using MWT. In this study, four 40-minute (1 session) MWT assessments per day was administered on Baseline, Day 1 and Day 7. MWT sleep latency ranges from 0 to 40 minutes, with longer sleep latency indicating greater ability to stay awake.
arm group label: Cohort A1; TAK-925 (Dose Level A1)
arm group type: Experimental
description: TAK-925, Dose Level A, once daily for up to 7 days in healthy participants.
arm group label: Cohort A2; TAK-925 (Dose Level A2)
arm group type: Experimental
description: TAK-925, Dose Level A2, once daily for up to 7 days in healthy participants. Dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts.
arm group label: Cohort A3; TAK-925 (Dose Level A3)
arm group type: Experimental
description: TAK-925, Dose Level A3, once daily for up to 7 days in healthy participants. This group is an additional optional cohort and dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts.
arm group label: Cohort A4; TAK-925 (Dose Level A4)
arm group type: Experimental
description: TAK-925, Dose Level A4, once daily for up to 7 days in healthy participants. This group is an additional optional cohort and dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts.
arm group label: Cohort A5; TAK-925 (Dose Level A5)
arm group type: Experimental
description: TAK-925, Dose Level A5, once daily for up to 7 days in healthy participants. This group is an additional optional cohort and dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts.
arm group label: Cohort A6; TAK-925 (Dose Level A6)
arm group type: Experimental
description: TAK-925, Dose Level A6, once daily for up to 7 days in healthy elderly participants. This group is an additional optional cohort and dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts.
arm group label: Part A (Cohorts A1-A6); TAK-925 Placebo
arm group type: Placebo Comparator
description: TAK-925 Placebo, once daily for up to 7 days in healthy participants.
arm group label: Cohort B1; TAK-925 (Dose Level B1)
arm group type: Experimental
description: TAK-925, Dose Level B1, once daily for up to 7 days in participants with narcolepsy.
arm group label: Cohort B2; TAK-925 (Dose Level B2)
arm group type: Experimental
description: TAK-925, Dose Level B2, once daily for up to 7 days in participants with narcolepsy. Dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts.
arm group label: Cohort B3; TAK-925 (Dose Level B3)
arm group type: Experimental
description: TAK-925, Dose Level B3, once daily for up to 7 days in participants with narcolepsy. This group is an additional optional cohort and dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts.
arm group label: Cohort B4; TAK-925 (Dose Level B4)
arm group type: Experimental
description: TAK-925, Dose Level B4, once daily for up to 7 days in participants with narcolepsy. This group is an additional optional cohort and dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts.
arm group label: Part B (Cohorts B1-B4); TAK-925 Placebo
arm group type: Placebo Comparator
description: TAK-925 Placebo, once daily for up to 7 days in participants with narcolepsy.
arm group label: Cohort C1; TAK-925 (Dose Level C1)
arm group type: Experimental
description: TAK-925, Dose Level C1, once daily for up to 7 days in participants with narcolepsy. Dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts.
arm group label: Cohort C2; TAK-925 (Dose Level C2)
arm group type: Experimental
description: TAK-925, Dose Level C2, once daily for up to 7 days in participants with narcolepsy. This group is an additional optional cohort and dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts.
arm group label: Part C (Cohorts C1-C2); TAK-925 Placebo
arm group type: Placebo Comparator
description: TAK-925 Placebo, once daily for up to 7 days in participants with narcolepsy.
arm group label: Cohort A'1; TAK-925 (Dose Level A'1)
arm group type: Experimental
description: TAK-925, Dose Level A'1, single dose in healthy participants.
arm group label: Cohort A'2; TAK-925 (Dose Level A'2)
arm group type: Experimental
description: TAK-925, Dose Level A'2, single dose in healthy participants. Dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts.
intervention type: Drug
intervention name: TAK-925
description: TAK-925
arm group label: Cohort A'1; TAK-925 (Dose Level A'1)
arm group label: Cohort A'2; TAK-925 (Dose Level A'2)
arm group label: Cohort A1; TAK-925 (Dose Level A1)
arm group label: Cohort A2; TAK-925 (Dose Level A2)
arm group label: Cohort A3; TAK-925 (Dose Level A3)
arm group label: Cohort A4; TAK-925 (Dose Level A4)
arm group label: Cohort A5; TAK-925 (Dose Level A5)
arm group label: Cohort A6; TAK-925 (Dose Level A6)
arm group label: Cohort B1; TAK-925 (Dose Level B1)
arm group label: Cohort B2; TAK-925 (Dose Level B2)
arm group label: Cohort B3; TAK-925 (Dose Level B3)
arm group label: Cohort B4; TAK-925 (Dose Level B4)
arm group label: Cohort C1; TAK-925 (Dose Level C1)
arm group label: Cohort C2; TAK-925 (Dose Level C2)
intervention type: Drug
intervention name: Placebo
description: TAK-925 Placebo
arm group label: Part A (Cohorts A1-A6); TAK-925 Placebo
arm group label: Part B (Cohorts B1-B4); TAK-925 Placebo
arm group label: Part C (Cohorts C1-C2); TAK-925 Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Medical Director
role: Study Director
affiliation: Takeda
facility: 
facility: 
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Narcolepsy
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: 