<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/NCT02201056</url>
  </required_header>
  <id_info>
    <org_study_id>TAK-935_101</org_study_id>
    <secondary_id>U111-1155-6022</secondary_id>
    <nct_id>NCT02201056</nct_id>
  </id_info>
  <brief_title>Safety, Tolerability, and Pharmacokinetics of Escalating Single Doses of TAK-935</brief_title>
  <official_title>A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability and Pharmacokinetic Study of Escalating Single Doses of TAK-935 in Healthy Subjects</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to characterize the safety and tolerability profile of TAK-935&#xD;
      in healthy participants when administered as a single dose of oral solution at escalating&#xD;
      dose levels.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The drug being tested in this study is TAK-935. TAK-935 is being tested to find a safe and&#xD;
      well-tolerated dose and to assess how TAK-935 is processed by the body. This study will look&#xD;
      at side effects and lab results in people who take TAK-935 and is designed as a randomized&#xD;
      dose-rising study.&#xD;
&#xD;
      The study will consist of 6 Cohorts with 8 participants in each Cohort. In each Cohort, 6&#xD;
      participants will receive a single dose of TAK-935 and 2 participants will receive placebo&#xD;
      after a 10-hour fast. The starting dose will be 15 mg followed by planned doses of 50, 200,&#xD;
      600, 900 and not to exceed 1350 mg in subsequent cohorts.&#xD;
&#xD;
      This single-center trial will be conducted in the United States. The overall time to&#xD;
      participate in this study is up to 51 days. Participants will make 2 visits to the clinic,&#xD;
      including one 7-day period of confinement to the clinic. All participants will be contacted&#xD;
      by telephone 14 days after the dose of study drug for a follow-up assessment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE)</measure>
    <time_frame>Day 1 to Day 30</time_frame>
    <description>An adverse event (AE) is 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 (eg, 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 treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug and within 30 days after the last dose of study drug.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Safety Laboratory Tests at Least Once Post-dose</measure>
    <time_frame>Day 1 to Day 14</time_frame>
    <description>The percentage of participants with any markedly abnormal standard safety laboratory values (hematology, serum chemistries, and urinalysis) collected during the treatment period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Meet Markedly Abnormal Criteria, for Vital Sign Measurements at Least Once Post-dose</measure>
    <time_frame>Day 1 to Day 14</time_frame>
    <description>The percentage of participants with any markedly abnormal vital signs (oral temperature, respiration rate, pulse, and blood pressure) collected during the treatment period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Electrocardiogram (ECG) Measurements at Least Once Post-dose</measure>
    <time_frame>Day 1 to Day 14</time_frame>
    <description>The percentage of participants with any markedly abnormal criteria for standard 12-lead ECG measured collected during the treatment period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cmax: Maximum Observed Plasma Concentration for TAK-935</measure>
    <time_frame>Multiple time-points (Up to 96 hours) post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-935</measure>
    <time_frame>Multiple time-points (Up to 96 hours) post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity of TAK-935</measure>
    <time_frame>Multiple time-points (Up to 96 hours) post-dose</time_frame>
  </secondary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Cohort 1: TAK-935 15 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAK-935 15 mg solution, orally, once, on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2: TAK-935 50 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAK-935 50 mg solution, orally, once, on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 3: TAK-935 200 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAK-935 200 mg solution, orally, once, on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 4: TAK-935 600 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAK-935 600 mg solution, orally, once, on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 5: TAK-935 900 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAK-935 900 mg solution, orally, once, on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 6: TAK-935 1350 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAK-935 1350 mg solution, orally, once, on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohorts 1-6: Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>TAK-935 placebo-matching solution, orally, once, on Day 1.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TAK-935</intervention_name>
    <description>TAK-935 oral solution</description>
    <arm_group_label>Cohort 1: TAK-935 15 mg</arm_group_label>
    <arm_group_label>Cohort 2: TAK-935 50 mg</arm_group_label>
    <arm_group_label>Cohort 3: TAK-935 200 mg</arm_group_label>
    <arm_group_label>Cohort 4: TAK-935 600 mg</arm_group_label>
    <arm_group_label>Cohort 5: TAK-935 900 mg</arm_group_label>
    <arm_group_label>Cohort 6: TAK-935 1350 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>TAK-935 placebo-matching oral solution</description>
    <arm_group_label>Cohorts 1-6: Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Is a healthy male or female adult who is 19 to 55 years of age inclusive at the time&#xD;
             of informed consent.&#xD;
&#xD;
          2. Weighs at least 45 kg and has a body mass index (BMI) between 18.0 and 30.0 kg/m^2,&#xD;
             inclusive at the Screening Visit.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Has uncontrolled, clinically significant neurological (including seizure disorders),&#xD;
             cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological,&#xD;
             immunologic, endocrine disease, or psychiatric disorder, or other abnormality.&#xD;
&#xD;
          2. Has a known hypersensitivity to any component of the formulation of TAK-935.&#xD;
&#xD;
          3. There is any finding in the participant's medical history, significant results from&#xD;
             physical examination, or safety laboratory tests.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director Clinical Science</last_name>
    <role>Study Director</role>
    <affiliation>Takeda</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>July 23, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <results_first_submitted>June 1, 2016</results_first_submitted>
  <results_first_submitted_qc>June 1, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">July 12, 2016</results_first_posted>
  <last_update_submitted>June 1, 2016</last_update_submitted>
  <last_update_submitted_qc>June 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 12, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Drug Therapy</keyword>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants took part in the study at 1 investigative site in the United States from 09 July 2014 to 30 July 2015.</recruitment_details>
      <pre_assignment_details>Healthy Volunteers were enrolled in 1 of 7 treatment groups, once a day placebo, TAK 935 15 mg, 50 mg, 200 mg, 600 mg, 900 mg or 1350 mg.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Cohorts 1-6: Placebo</title>
          <description>TAK-935 placebo-matching solution, orally, once, on Day 1.</description>
        </group>
        <group group_id="P2">
          <title>Cohort 1: TAK-935 15 mg</title>
          <description>TAK-935 15 mg solution, orally, once, on Day 1.</description>
        </group>
        <group group_id="P3">
          <title>Cohort 2: TAK-935 50 mg</title>
          <description>TAK-935 50 mg solution, orally, once, on Day 1.</description>
        </group>
        <group group_id="P4">
          <title>Cohort 3: TAK-935 200 mg</title>
          <description>TAK-935 200 mg solution, orally, once, on Day 1.</description>
        </group>
        <group group_id="P5">
          <title>Cohort 4: TAK-935 600 mg</title>
          <description>TAK-935 600 mg solution, orally, once, on Day 1.</description>
        </group>
        <group group_id="P6">
          <title>Cohort 5: TAK-935 900 mg</title>
          <description>TAK-935 900 mg solution, orally, once, on Day 1.</description>
        </group>
        <group group_id="P7">
          <title>Cohort 6: TAK-935 1350 mg</title>
          <description>TAK-935 1350 mg solution, orally, once, on Day 1.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="6"/>
                <participants group_id="P7" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="6"/>
                <participants group_id="P7" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>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_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Analysis was performed on safety set which included all participants who were enrolled and received study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>Cohorts 1-6: Placebo</title>
          <description>TAK-935 placebo-matching solution, orally, once, on Day 1.</description>
        </group>
        <group group_id="B2">
          <title>Cohort 1: TAK-935 15 mg</title>
          <description>TAK-935 15 mg solution, orally, once, on Day 1.</description>
        </group>
        <group group_id="B3">
          <title>Cohort 2: TAK-935 50 mg</title>
          <description>TAK-935 50 mg solution, orally, once, on Day 1.</description>
        </group>
        <group group_id="B4">
          <title>Cohort 3: TAK-935 200 mg</title>
          <description>TAK-935 200 mg solution, orally, once, on Day 1.</description>
        </group>
        <group group_id="B5">
          <title>Cohort 4: TAK-935 600 mg</title>
          <description>TAK-935 600 mg solution, orally, once, on Day 1.</description>
        </group>
        <group group_id="B6">
          <title>Cohort 5: TAK-935 900 mg</title>
          <description>TAK-935 900 mg solution, orally, once, on Day 1.</description>
        </group>
        <group group_id="B7">
          <title>Cohort 6: TAK-935 1350 mg</title>
          <description>TAK-935 1350 mg solution, orally, once, on Day 1.</description>
        </group>
        <group group_id="B8">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="12"/>
            <count group_id="B2" value="6"/>
            <count group_id="B3" value="6"/>
            <count group_id="B4" value="6"/>
            <count group_id="B5" value="6"/>
            <count group_id="B6" value="6"/>
            <count group_id="B7" value="6"/>
            <count group_id="B8" value="48"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35.9" spread="10.41"/>
                    <measurement group_id="B2" value="34.2" spread="8.21"/>
                    <measurement group_id="B3" value="34.3" spread="10.93"/>
                    <measurement group_id="B4" value="29.8" spread="6.74"/>
                    <measurement group_id="B5" value="35.3" spread="13.31"/>
                    <measurement group_id="B6" value="30.5" spread="10.33"/>
                    <measurement group_id="B7" value="32.8" spread="12.97"/>
                    <measurement group_id="B8" value="33.6" spread="10.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="6"/>
                    <measurement group_id="B7" value="6"/>
                    <measurement group_id="B8" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="4"/>
                    <measurement group_id="B7" value="5"/>
                    <measurement group_id="B8" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Multiracial</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="6"/>
                    <measurement group_id="B7" value="6"/>
                    <measurement group_id="B8" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="6"/>
                    <measurement group_id="B7" value="6"/>
                    <measurement group_id="B8" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="170.8" spread="5.99"/>
                    <measurement group_id="B2" value="165.0" spread="11.52"/>
                    <measurement group_id="B3" value="175.0" spread="5.59"/>
                    <measurement group_id="B4" value="178.7" spread="7.31"/>
                    <measurement group_id="B5" value="173.5" spread="8.89"/>
                    <measurement group_id="B6" value="161.5" spread="2.88"/>
                    <measurement group_id="B7" value="165.5" spread="2.59"/>
                    <measurement group_id="B8" value="170.1" spread="8.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70.23" spread="10.478"/>
                    <measurement group_id="B2" value="68.88" spread="19.873"/>
                    <measurement group_id="B3" value="78.25" spread="13.623"/>
                    <measurement group_id="B4" value="80.18" spread="12.039"/>
                    <measurement group_id="B5" value="76.85" spread="9.465"/>
                    <measurement group_id="B6" value="70.10" spread="6.214"/>
                    <measurement group_id="B7" value="69.28" spread="10.981"/>
                    <measurement group_id="B8" value="73.00" spread="12.178"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.00" spread="2.532"/>
                    <measurement group_id="B2" value="24.86" spread="4.073"/>
                    <measurement group_id="B3" value="25.44" spread="3.361"/>
                    <measurement group_id="B4" value="25.05" spread="3.039"/>
                    <measurement group_id="B5" value="25.51" spread="2.539"/>
                    <measurement group_id="B6" value="26.88" spread="2.313"/>
                    <measurement group_id="B7" value="25.34" spread="4.251"/>
                    <measurement group_id="B8" value="25.13" spread="3.064"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE)</title>
        <description>An adverse event (AE) is 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 (eg, 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 treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug and within 30 days after the last dose of study drug.</description>
        <time_frame>Day 1 to Day 30</time_frame>
        <population>Safety set included all participants who were enrolled and received study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohorts 1-6: Placebo</title>
            <description>TAK-935 placebo-matching solution, orally, once, on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1: TAK-935 15 mg</title>
            <description>TAK-935 15 mg solution, orally, once, on Day 1.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: TAK-935 50 mg</title>
            <description>TAK-935 50 mg solution, orally, once, on Day 1.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 3: TAK-935 200 mg</title>
            <description>TAK-935 200 mg solution, orally, once, on Day 1.</description>
          </group>
          <group group_id="O5">
            <title>Cohort 4: TAK-935 600 mg</title>
            <description>TAK-935 600 mg solution, orally, once, on Day 1.</description>
          </group>
          <group group_id="O6">
            <title>Cohort 5: TAK-935 900 mg</title>
            <description>TAK-935 900 mg solution, orally, once, on Day 1.</description>
          </group>
          <group group_id="O7">
            <title>Cohort 6: TAK-935 1350 mg</title>
            <description>TAK-935 1350 mg solution, orally, once, on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE)</title>
          <description>An adverse event (AE) is 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 (eg, 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 treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug and within 30 days after the last dose of study drug.</description>
          <population>Safety set included all participants who were enrolled and received study drug.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.7"/>
                    <measurement group_id="O2" value="33.3"/>
                    <measurement group_id="O3" value="16.7"/>
                    <measurement group_id="O4" value="33.3"/>
                    <measurement group_id="O5" value="83.3"/>
                    <measurement group_id="O6" value="33.3"/>
                    <measurement group_id="O7" value="33.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Safety Laboratory Tests at Least Once Post-dose</title>
        <description>The percentage of participants with any markedly abnormal standard safety laboratory values (hematology, serum chemistries, and urinalysis) collected during the treatment period.</description>
        <time_frame>Day 1 to Day 14</time_frame>
        <population>Safety set included all participants who were enrolled and received study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohorts 1-6: Placebo</title>
            <description>TAK-935 placebo-matching solution, orally, once, on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1: TAK-935 15 mg</title>
            <description>TAK-935 15 mg solution, orally, once, on Day 1.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: TAK-935 50 mg</title>
            <description>TAK-935 50 mg solution, orally, once, on Day 1.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 3: TAK-935 200 mg</title>
            <description>TAK-935 200 mg solution, orally, once, on Day 1.</description>
          </group>
          <group group_id="O5">
            <title>Cohort 4: TAK-935 600 mg</title>
            <description>TAK-935 600 mg solution, orally, once, on Day 1.</description>
          </group>
          <group group_id="O6">
            <title>Cohort 5: TAK-935 900 mg</title>
            <description>TAK-935 900 mg solution, orally, once, on Day 1.</description>
          </group>
          <group group_id="O7">
            <title>Cohort 6: TAK-935 1350 mg</title>
            <description>TAK-935 1350 mg solution, orally, once, on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Safety Laboratory Tests at Least Once Post-dose</title>
          <description>The percentage of participants with any markedly abnormal standard safety laboratory values (hematology, serum chemistries, and urinalysis) collected during the treatment period.</description>
          <population>Safety set included all participants who were enrolled and received study drug.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="16.7"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Meet Markedly Abnormal Criteria, for Vital Sign Measurements at Least Once Post-dose</title>
        <description>The percentage of participants with any markedly abnormal vital signs (oral temperature, respiration rate, pulse, and blood pressure) collected during the treatment period.</description>
        <time_frame>Day 1 to Day 14</time_frame>
        <population>Safety set included all participants who were enrolled and received study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohorts 1-6: Placebo</title>
            <description>TAK-935 placebo-matching solution, orally, once, on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1: TAK-935 15 mg</title>
            <description>TAK-935 15 mg solution, orally, once, on Day 1.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: TAK-935 50 mg</title>
            <description>TAK-935 50 mg solution, orally, once, on Day 1.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 3: TAK-935 200 mg</title>
            <description>TAK-935 200 mg solution, orally, once, on Day 1.</description>
          </group>
          <group group_id="O5">
            <title>Cohort 4: TAK-935 600 mg</title>
            <description>TAK-935 600 mg solution, orally, once, on Day 1.</description>
          </group>
          <group group_id="O6">
            <title>Cohort 5: TAK-935 900 mg</title>
            <description>TAK-935 900 mg solution, orally, once, on Day 1.</description>
          </group>
          <group group_id="O7">
            <title>Cohort 6: TAK-935 1350 mg</title>
            <description>TAK-935 1350 mg solution, orally, once, on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Meet Markedly Abnormal Criteria, for Vital Sign Measurements at Least Once Post-dose</title>
          <description>The percentage of participants with any markedly abnormal vital signs (oral temperature, respiration rate, pulse, and blood pressure) collected during the treatment period.</description>
          <population>Safety set included all participants who were enrolled and received study drug.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.0"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="66.7"/>
                    <measurement group_id="O4" value="66.7"/>
                    <measurement group_id="O5" value="66.7"/>
                    <measurement group_id="O6" value="66.7"/>
                    <measurement group_id="O7" value="66.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Electrocardiogram (ECG) Measurements at Least Once Post-dose</title>
        <description>The percentage of participants with any markedly abnormal criteria for standard 12-lead ECG measured collected during the treatment period.</description>
        <time_frame>Day 1 to Day 14</time_frame>
        <population>Safety set included all participants who were enrolled and received study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohorts 1-6: Placebo</title>
            <description>TAK-935 placebo-matching solution, orally, once, on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1: TAK-935 15 mg</title>
            <description>TAK-935 15 mg solution, orally, once, on Day 1.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: TAK-935 50 mg</title>
            <description>TAK-935 50 mg solution, orally, once, on Day 1.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 3: TAK-935 200 mg</title>
            <description>TAK-935 200 mg solution, orally, once, on Day 1.</description>
          </group>
          <group group_id="O5">
            <title>Cohort 4: TAK-935 600 mg</title>
            <description>TAK-935 600 mg solution, orally, once, on Day 1.</description>
          </group>
          <group group_id="O6">
            <title>Cohort 5: TAK-935 900 mg</title>
            <description>TAK-935 900 mg solution, orally, once, on Day 1.</description>
          </group>
          <group group_id="O7">
            <title>Cohort 6: TAK-935 1350 mg</title>
            <description>TAK-935 1350 mg solution, orally, once, on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Electrocardiogram (ECG) Measurements at Least Once Post-dose</title>
          <description>The percentage of participants with any markedly abnormal criteria for standard 12-lead ECG measured collected during the treatment period.</description>
          <population>Safety set included all participants who were enrolled and received study drug.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.0"/>
                    <measurement group_id="O2" value="66.7"/>
                    <measurement group_id="O3" value="83.3"/>
                    <measurement group_id="O4" value="50.0"/>
                    <measurement group_id="O5" value="16.7"/>
                    <measurement group_id="O6" value="33.3"/>
                    <measurement group_id="O7" value="33.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cmax: Maximum Observed Plasma Concentration for TAK-935</title>
        <time_frame>Multiple time-points (Up to 96 hours) post-dose</time_frame>
        <population>Pharmacokinetic (PK) set included all participants in the safety set who had at least 1 measurable plasma or urine concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: TAK-935 15 mg</title>
            <description>TAK-935 15 mg solution, orally, once, on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: TAK-935 50 mg</title>
            <description>TAK-935 50 mg solution, orally, once, on Day 1.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3: TAK-935 200 mg</title>
            <description>TAK-935 200 mg solution, orally, once, on Day 1.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4: TAK-935 600 mg</title>
            <description>TAK-935 600 mg solution, orally, once, on Day 1.</description>
          </group>
          <group group_id="O5">
            <title>Cohort 5: TAK-935 900 mg</title>
            <description>TAK-935 900 mg solution, orally, once, on Day 1.</description>
          </group>
          <group group_id="O6">
            <title>Cohort 6: TAK-935 1350 mg</title>
            <description>TAK-935 1350 mg solution, orally, once, on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax: Maximum Observed Plasma Concentration for TAK-935</title>
          <population>Pharmacokinetic (PK) set included all participants in the safety set who had at least 1 measurable plasma or urine concentration.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.533" spread="41.2350"/>
                    <measurement group_id="O2" value="210.150" spread="153.0463"/>
                    <measurement group_id="O3" value="571.167" spread="257.8002"/>
                    <measurement group_id="O4" value="4551.667" spread="2573.5067"/>
                    <measurement group_id="O5" value="5080.000" spread="1801.9323"/>
                    <measurement group_id="O6" value="7953.333" spread="2151.3035"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-935</title>
        <time_frame>Multiple time-points (Up to 96 hours) post-dose</time_frame>
        <population>PK set included all participants in the safety set who had at least 1 measurable plasma or urine concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: TAK-935 15 mg</title>
            <description>TAK-935 15 mg solution, orally, once, on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: TAK-935 50 mg</title>
            <description>TAK-935 50 mg solution, orally, once, on Day 1.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3: TAK-935 200 mg</title>
            <description>TAK-935 200 mg solution, orally, once, on Day 1.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4: TAK-935 600 mg</title>
            <description>TAK-935 600 mg solution, orally, once, on Day 1.</description>
          </group>
          <group group_id="O5">
            <title>Cohort 5: TAK-935 900 mg</title>
            <description>TAK-935 900 mg solution, orally, once, on Day 1.</description>
          </group>
          <group group_id="O6">
            <title>Cohort 6: TAK-935 1350 mg</title>
            <description>TAK-935 1350 mg solution, orally, once, on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-935</title>
          <population>PK set included all participants in the safety set who had at least 1 measurable plasma or urine concentration.</population>
          <units>ng*hr/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.323" spread="28.9569"/>
                    <measurement group_id="O2" value="168.736" spread="88.3702"/>
                    <measurement group_id="O3" value="562.660" spread="196.6517"/>
                    <measurement group_id="O4" value="5791.561" spread="3427.9888"/>
                    <measurement group_id="O5" value="7619.088" spread="1928.2091"/>
                    <measurement group_id="O6" value="13501.049" spread="5778.0847"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity of TAK-935</title>
        <time_frame>Multiple time-points (Up to 96 hours) post-dose</time_frame>
        <population>PK set included all participants in the safety set who had at least 1 measurable plasma or urine concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: TAK-935 15 mg</title>
            <description>TAK-935 15 mg solution, orally, once, on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: TAK-935 50 mg</title>
            <description>TAK-935 50 mg solution, orally, once, on Day 1.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3: TAK-935 200 mg</title>
            <description>TAK-935 200 mg solution, orally, once, on Day 1.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4: TAK-935 600 mg</title>
            <description>TAK-935 600 mg solution, orally, once, on Day 1.</description>
          </group>
          <group group_id="O5">
            <title>Cohort 5: TAK-935 900 mg</title>
            <description>TAK-935 900 mg solution, orally, once, on Day 1.</description>
          </group>
          <group group_id="O6">
            <title>Cohort 6: TAK-935 1350 mg</title>
            <description>TAK-935 1350 mg solution, orally, once, on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity of TAK-935</title>
          <population>PK set included all participants in the safety set who had at least 1 measurable plasma or urine concentration.</population>
          <units>ng*hr/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.290" spread="6.7061"/>
                    <measurement group_id="O2" value="172.430" spread="107.0799"/>
                    <measurement group_id="O3" value="621.369" spread="240.5953"/>
                    <measurement group_id="O4" value="5809.066" spread="3427.5393"/>
                    <measurement group_id="O5" value="7660.961" spread="1962.0905"/>
                    <measurement group_id="O6" value="13541.772" spread="5763.4722"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>30 Days</time_frame>
      <desc>At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.</desc>
      <group_list>
        <group group_id="E1">
          <title>Cohorts 1-6: Placebo</title>
          <description>TAK-935 placebo-matching solution, orally, once, on Day 1.</description>
        </group>
        <group group_id="E2">
          <title>Cohort 1: TAK-935 15 mg</title>
          <description>TAK-935 15 mg solution, orally, once, on Day 1.</description>
        </group>
        <group group_id="E3">
          <title>Cohort 2: TAK-935 50 mg</title>
          <description>TAK-935 50 mg solution, orally, once, on Day 1.</description>
        </group>
        <group group_id="E4">
          <title>Cohort 3: TAK-935 200 mg</title>
          <description>TAK-935 200 mg solution, orally, once, on Day 1.</description>
        </group>
        <group group_id="E5">
          <title>Cohort 4: TAK-935 600 mg</title>
          <description>TAK-935 600 mg solution, orally, once, on Day 1.</description>
        </group>
        <group group_id="E6">
          <title>Cohort 5: TAK-935 900 mg</title>
          <description>TAK-935 900 mg solution, orally, once, on Day 1.</description>
        </group>
        <group group_id="E7">
          <title>Cohort 6: TAK-935 1350 mg</title>
          <description>TAK-935 1350 mg solution, orally, once, on Day 1.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (17.0)</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="5" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Paraesthesia oral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Application site dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Application site erosion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <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="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Application site erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Application site pruritus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Thirst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Musculoskeletal stiffness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="12"/>
                <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="2" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Dizziness postural</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Lethargy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Disturbance in attention</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Abnormal dreams</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <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="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Euphoric mood</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" 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="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Menstruation irregular</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Metrorrhagia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" 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="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Skin irritation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>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/NCT02201056
org study id: TAK-935_101
secondary id: U111-1155-6022
nct id: NCT02201056
lead sponsor: 
has dmc: No
The purpose of this study is to characterize the safety and tolerability profile of TAK-935
      in healthy participants when administered as a single dose of oral solution at escalating
      dose levels.
The drug being tested in this study is TAK-935. TAK-935 is being tested to find a safe and
      well-tolerated dose and to assess how TAK-935 is processed by the body. This study will look
      at side effects and lab results in people who take TAK-935 and is designed as a randomized
      dose-rising study.

      The study will consist of 6 Cohorts with 8 participants in each Cohort. In each Cohort, 6
      participants will receive a single dose of TAK-935 and 2 participants will receive placebo
      after a 10-hour fast. The starting dose will be 15 mg followed by planned doses of 50, 200,
      600, 900 and not to exceed 1350 mg in subsequent cohorts.

      This single-center trial will be conducted in the United States. The overall time to
      participate in this study is up to 51 days. Participants will make 2 visits to the clinic,
      including one 7-day period of confinement to the clinic. All participants will be contacted
      by telephone 14 days after the dose of study drug for a follow-up assessment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE)
time frame: Day 1 to Day 30
description: An adverse event (AE) is 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 (eg, 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 treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug and within 30 days after the last dose of study drug.
measure: Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Safety Laboratory Tests at Least Once Post-dose
time frame: Day 1 to Day 14
description: The percentage of participants with any markedly abnormal standard safety laboratory values (hematology, serum chemistries, and urinalysis) collected during the treatment period.
measure: Percentage of Participants Who Meet Markedly Abnormal Criteria, for Vital Sign Measurements at Least Once Post-dose
time frame: Day 1 to Day 14
description: The percentage of participants with any markedly abnormal vital signs (oral temperature, respiration rate, pulse, and blood pressure) collected during the treatment period.
measure: Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Electrocardiogram (ECG) Measurements at Least Once Post-dose
time frame: Day 1 to Day 14
description: The percentage of participants with any markedly abnormal criteria for standard 12-lead ECG measured collected during the treatment period.
measure: Cmax: Maximum Observed Plasma Concentration for TAK-935
time frame: Multiple time-points (Up to 96 hours) post-dose
measure: AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-935
time frame: Multiple time-points (Up to 96 hours) post-dose
measure: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity of TAK-935
time frame: Multiple time-points (Up to 96 hours) post-dose
arm group label: Cohort 1: TAK-935 15 mg
arm group type: Experimental
description: TAK-935 15 mg solution, orally, once, on Day 1.
arm group label: Cohort 2: TAK-935 50 mg
arm group type: Experimental
description: TAK-935 50 mg solution, orally, once, on Day 1.
arm group label: Cohort 3: TAK-935 200 mg
arm group type: Experimental
description: TAK-935 200 mg solution, orally, once, on Day 1.
arm group label: Cohort 4: TAK-935 600 mg
arm group type: Experimental
description: TAK-935 600 mg solution, orally, once, on Day 1.
arm group label: Cohort 5: TAK-935 900 mg
arm group type: Experimental
description: TAK-935 900 mg solution, orally, once, on Day 1.
arm group label: Cohort 6: TAK-935 1350 mg
arm group type: Experimental
description: TAK-935 1350 mg solution, orally, once, on Day 1.
arm group label: Cohorts 1-6: Placebo
arm group type: Placebo Comparator
description: TAK-935 placebo-matching solution, orally, once, on Day 1.
intervention type: Drug
intervention name: TAK-935
description: TAK-935 oral solution
arm group label: Cohort 1: TAK-935 15 mg
arm group label: Cohort 2: TAK-935 50 mg
arm group label: Cohort 3: TAK-935 200 mg
arm group label: Cohort 4: TAK-935 600 mg
arm group label: Cohort 5: TAK-935 900 mg
arm group label: Cohort 6: TAK-935 1350 mg
intervention type: Drug
intervention name: Placebo
description: TAK-935 placebo-matching oral solution
arm group label: Cohorts 1-6: Placebo
criteria: 
gender: All
minimum age: 19 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Medical Director Clinical Science
role: Study Director
affiliation: Takeda
facility: 
country: United States
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 