<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/NCT03277274</url>
  </required_header>
  <id_info>
    <org_study_id>TAK-954-1006</org_study_id>
    <secondary_id>2017-000714-37</secondary_id>
    <secondary_id>U1111-1196-9190</secondary_id>
    <nct_id>NCT03277274</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Effect of Hepatic Impairment on the Single Dose Pharmacokinetics (PK) of Intravenous TAK-954</brief_title>
  <official_title>A Phase 1, Non-Randomized, Open-Label Trial to Evaluate the Effect of Hepatic Impairment on the Single Dose Pharmacokinetics of Intravenous TAK-954</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 evaluate the effect of varying degrees of hepatic function on&#xD;
      the single dose PK of IV TAK-954.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The drug being tested in this study is called TAK-954. This study will evaluate the safety&#xD;
      and tolerability of single intravenous doses of TAK-954 in participants with varying degrees&#xD;
      of hepatic function.&#xD;
&#xD;
      The study will enroll approximately up to 32 participants. Participants will be enrolled in&#xD;
      one of the 4 treatment groups based on their degree of hepatic impairment which will be&#xD;
      determined based on Child-Pugh Score as follow:&#xD;
&#xD;
        -  Group 1 TAK-954 0.2 mg: Mild Hepatic Impairment (Child Pugh Class A)&#xD;
&#xD;
        -  Group 2 TAK-954 0.2 mg: Moderate Hepatic Impairment (Child Pugh Class B)&#xD;
&#xD;
        -  Group 3 TAK-954 0.2 mg: Severe Hepatic Impairment (Child Pugh Class C)&#xD;
&#xD;
        -  Group 4 TAK-954 0.2 mg: Healthy Participants&#xD;
&#xD;
      The Child-Pugh classification will assess the severity of 5 hepatic parameters (total serum&#xD;
      bilirubin, serum albumin, prothrombin time, ascites and encephalopathy grade) on a scale of 1&#xD;
      (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe)&#xD;
      where higher score indicates more severity.&#xD;
&#xD;
      All participants will receive a single dose of TAK-954 0.2 mg on Day 1.&#xD;
&#xD;
      This study may have a full study design, where Group 1 to Group 4 will enroll approximately 8&#xD;
      participants in each group or a reduced study design, where no participants will be enrolled&#xD;
      in Group 1 and approximately 8 participants will be enrolled in Group 2 to Group 4.&#xD;
&#xD;
      This multi-center trial will be conducted in Czech Republic and Slovakia. The overall time to&#xD;
      participate in this study is approximately 7 weeks. Participants will remain confined to the&#xD;
      clinic for 4 days, with 2 further out-patient visits, and will make a final visit to the&#xD;
      clinic 10-14 days after receiving their last dose of TAK-954 for a follow-up assessment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 9, 2017</start_date>
  <completion_date type="Actual">September 10, 2018</completion_date>
  <primary_completion_date type="Actual">September 1, 2018</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cmax: Maximum Observed Plasma Concentration for TAK-954 (Total and Free)</measure>
    <time_frame>Day 1 pre-infusion and at multiple time points (up to 96 hours) post-infusion</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUClast: Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-954 (Total and Free)</measure>
    <time_frame>Day 1 pre-infusion and at multiple time points (up to 96 hours) post-infusion</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC∞: Area Under the Concentration-time Curve From Time 0 to Infinity for TAK-954 (Total and Free)</measure>
    <time_frame>Day 1 pre-infusion and at multiple time points (up to 96 hours) post-infusion</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinically Significant Physical Examination Findings</measure>
    <time_frame>Up to 14 days after the last dose of study drug (Day 15)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Markedly Abnormal Electrocardiograms (ECGs)</measure>
    <time_frame>Up to 14 days after the last dose of study drug (Day 15)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Markedly Abnormal Values of Vital Signs</measure>
    <time_frame>Up to 14 days after the last dose of study drug (Day 15)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Values</measure>
    <time_frame>Up to 14 days after the last dose of study drug (Day 15)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)</measure>
    <time_frame>Baseline up to 30 days after last dose of study drug (Day 31)</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Hepatic Impairment</condition>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Group 1 Mild Hepatic Impairment: TAK-954 0.2 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAK-954 0.2 milligram (mg), intravenous, administered as 60-minute infusion, once on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2 Moderate Hepatic Impairment: TAK-954 0.2 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAK-954 0.2 mg, intravenous, administered as 60-minute infusion, once on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3 Severe Hepatic Impairment: TAK-954 0.2 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAK-954 0.2 mg, intravenous, administered as 60-minute infusion, once on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 4 Healthy Participants: TAK-954 0.2 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAK-954 0.2 mg, intravenous, administered as 60-minute infusion, once on Day 1.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TAK-954</intervention_name>
    <description>TAK-954 intravenous infusion.</description>
    <arm_group_label>Group 1 Mild Hepatic Impairment: TAK-954 0.2 mg</arm_group_label>
    <arm_group_label>Group 2 Moderate Hepatic Impairment: TAK-954 0.2 mg</arm_group_label>
    <arm_group_label>Group 3 Severe Hepatic Impairment: TAK-954 0.2 mg</arm_group_label>
    <arm_group_label>Group 4 Healthy Participants: TAK-954 0.2 mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male and female participants (non-childbearing potential), with a body mass index&#xD;
             (BMI) between 18 to 35 kilogram per square meter (kg/m^2) (All participants).&#xD;
&#xD;
          2. Participants with hepatic impairment who are medically stable as determined by the&#xD;
             investigator, based on medical history and clinical evaluations including physical&#xD;
             examinations, clinical laboratory tests, vital sign measurements, and 12-lead ECGs&#xD;
             performed at the Screening Visit and at check-in on Day -1 (Group 1 to 3).&#xD;
&#xD;
          3. Healthy participants (Group 4).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Participants who have:&#xD;
&#xD;
          1. A history of hepatic carcinoma, hepatorenal syndrome, or presence of a liver mass by&#xD;
             ultrasound, CT or MRI, or acute liver disease caused by an infection or drug toxicity&#xD;
             (Group 1 to 3).&#xD;
&#xD;
          2. Have severe hepatic encephalopathy ([greater than] &gt; Grade II Portal Systemic&#xD;
             Encephalopathy Score) (Group 1 to 3).&#xD;
&#xD;
          3. Surgical porto-systemic shunts, including transjugular intrahepatic portosystemic&#xD;
             shunt (Group 1 to 3).&#xD;
&#xD;
          4. A history of gastrointestinal hemorrhage due to esophageal varices or peptic ulcers&#xD;
             less than 1 month prior to trial entry (Group 1 to 3).&#xD;
&#xD;
          5. Bilirubin levels above 5 times the upper limit of normal (ULN) at screening or Day -1&#xD;
             for Groups 1 and 2, there is no limit for Group 3.&#xD;
&#xD;
          6. Severe/advanced ascites and/or pleural effusion which requires emptying and albumin&#xD;
             supplementation, as judged by the investigator (Group 1 to 3).&#xD;
&#xD;
          7. Renal creatinine clearance (CLcr) less than or equal to (&lt;=) 50 milliliter per minute&#xD;
             (mL/min), calculated using the Cockcroft-Gault equation from the serum creatinine&#xD;
             measurement taken at screening (Group 1 to 3).&#xD;
&#xD;
          8. Who have a history of clinically significant endocrine, gastrointestinal (GI)&#xD;
             (including motility disorder and intestinal obstruction), cardiovascular,&#xD;
             hematological, hepatic, immunological, renal, respiratory, genitourinary, or major&#xD;
             neurological (including stroke and chronic seizures) abnormalities or diseases will be&#xD;
             excluded from the trial (Group 4).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 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>PRA CZ, s.r.o</name>
      <address>
        <city>Praha 7</city>
        <state>Praha</state>
        <zip>170 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Summit Center of Clinical Research</name>
      <address>
        <city>Bratislava</city>
        <zip>83101</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czechia</country>
    <country>Slovakia</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <results_first_submitted>August 28, 2019</results_first_submitted>
  <results_first_submitted_qc>August 28, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">September 25, 2019</results_first_posted>
  <last_update_submitted>August 28, 2019</last_update_submitted>
  <last_update_submitted_qc>August 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Drug Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 6, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/74/NCT03277274/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 5, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/74/NCT03277274/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants took part in the study at 2 investigative sites in Czech Republic and Slovakia from 09 November 2017 to 10 September 2018.</recruitment_details>
      <pre_assignment_details>Participants with normal hepatic function and hepatic impairment were enrolled in 1 of the groups:B(moderate), C(severe) or D(healthy) to receive TAK-954 0.2mg. Based on available safety and PK data from Group B, participants were enrolled in reduced study design and were not enrolled in GroupA(mild). Groups A-D are equal to Groups 1-4 in protocol.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Healthy Participants: TAK-954 0.2 mg</title>
          <description>TAK-954 0.2 milligram (mg), infusion, intravenously, once on Day 1.</description>
        </group>
        <group group_id="P2">
          <title>Group B, Moderate Hepatic Impairment: TAK-954 0.2 mg</title>
          <description>TAK-954 0.2 mg, infusion, intravenously, once on Day 1.</description>
        </group>
        <group group_id="P3">
          <title>Group C, Severe Hepatic Impairment: TAK-954 0.2 mg</title>
          <description>TAK-954 0.2 mg, infusion, intravenously, 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="8"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="7"/>
              </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_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The safety set consisted of all participants who were enrolled and received the study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>Healthy Participants: TAK-954 0.2 mg</title>
          <description>TAK-954 0.2 milligram (mg), infusion, intravenously, once on Day 1.</description>
        </group>
        <group group_id="B2">
          <title>Group B, Moderate Hepatic Impairment: TAK-954 0.2 mg</title>
          <description>TAK-954 0.2 mg, infusion, intravenously, once on Day 1.</description>
        </group>
        <group group_id="B3">
          <title>Group C, Severe Hepatic Impairment: TAK-954 0.2 mg</title>
          <description>TAK-954 0.2 mg, infusion, intravenously, once on Day 1.</description>
        </group>
        <group group_id="B4">
          <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="8"/>
            <count group_id="B2" value="10"/>
            <count group_id="B3" value="7"/>
            <count group_id="B4" value="25"/>
          </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="58.5" spread="9.46"/>
                    <measurement group_id="B2" value="55.6" spread="12.25"/>
                    <measurement group_id="B3" value="57.9" spread="12.88"/>
                    <measurement group_id="B4" value="57.2" spread="11.21"/>
                  </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="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_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>Czech Republic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Slovakia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="17"/>
                  </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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="89.95" spread="17.098"/>
                    <measurement group_id="B2" value="86.77" spread="19.823"/>
                    <measurement group_id="B3" value="87.19" spread="21.331"/>
                    <measurement group_id="B4" value="87.90" spread="18.667"/>
                  </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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31.1" spread="3.18"/>
                    <measurement group_id="B2" value="30.4" spread="5.02"/>
                    <measurement group_id="B3" value="27.9" spread="6.18"/>
                    <measurement group_id="B4" value="29.9" spread="4.87"/>
                  </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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="169.8" spread="11.30"/>
                    <measurement group_id="B2" value="168.0" spread="10.47"/>
                    <measurement group_id="B3" value="176.1" spread="6.28"/>
                    <measurement group_id="B4" value="170.8" spread="10.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Cmax: Maximum Observed Plasma Concentration for TAK-954 (Total and Free)</title>
        <time_frame>Day 1 pre-infusion and at multiple time points (up to 96 hours) post-infusion</time_frame>
        <population>The pharmacokinetic (PK) set consisted of all participants who were enrolled and received the correct dose of study drug and had at least 1 measurable plasma concentration or amount of drug in the urine for TAK-954.</population>
        <group_list>
          <group group_id="O1">
            <title>Healthy Participants: TAK-954 0.2 mg</title>
            <description>TAK-954 0.2 milligram (mg), infusion, intravenously, once on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Group B, Moderate Hepatic Impairment: TAK-954 0.2 mg</title>
            <description>TAK-954 0.2 mg, infusion, intravenously, once on Day 1.</description>
          </group>
          <group group_id="O3">
            <title>Group C, Severe Hepatic Impairment: TAK-954 0.2 mg</title>
            <description>TAK-954 0.2 mg, infusion, intravenously, once on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax: Maximum Observed Plasma Concentration for TAK-954 (Total and Free)</title>
          <population>The pharmacokinetic (PK) set consisted of all participants who were enrolled and received the correct dose of study drug and had at least 1 measurable plasma concentration or amount of drug in the urine for TAK-954.</population>
          <units>nanogram per milliliter (ng/mL)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TAK-954 (Total)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.629" spread="19.1"/>
                    <measurement group_id="O2" value="2.440" spread="25.3"/>
                    <measurement group_id="O3" value="1.893" spread="35.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TAK-954 (Free)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1381" spread="15.6"/>
                    <measurement group_id="O2" value="0.1799" spread="24.4"/>
                    <measurement group_id="O3" value="0.1778" spread="23.1"/>
                  </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>Other</non_inferiority_type>
            <non_inferiority_desc>TAK-954 (Total): An analysis of variance (ANOVA) were performed on log transformed Cmax (total TAK-954) to compare each hepatically impaired group with the normal hepatic function group.</non_inferiority_desc>
            <p_value>0.579</p_value>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>TAK-954 (Total): An ANOVA were performed on log transformed Cmax (total TAK-954) to compare each hepatically impaired group with the normal hepatic function group.</non_inferiority_desc>
            <p_value>0.026</p_value>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>TAK-954 (Free): An ANOVA were performed on log transformed Cmax (Free TAK-954) to compare each hepatically impaired group with the normal hepatic function group.</non_inferiority_desc>
            <p_value>0.020</p_value>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>TAK-954 (Free): An ANOVA were performed on log transformed Cmax (Free TAK-954) to compare each hepatically impaired group with the normal hepatic function group.</non_inferiority_desc>
            <p_value>0.031</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUClast: Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-954 (Total and Free)</title>
        <time_frame>Day 1 pre-infusion and at multiple time points (up to 96 hours) post-infusion</time_frame>
        <population>The PK set consisted of all participants who were enrolled and received the correct dose of study drug and had at least 1 measurable plasma concentration or amount of drug in the urine for TAK-954.</population>
        <group_list>
          <group group_id="O1">
            <title>Healthy Participants: TAK-954 0.2 mg</title>
            <description>TAK-954 0.2 milligram (mg), infusion, intravenously, once on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Group B, Moderate Hepatic Impairment: TAK-954 0.2 mg</title>
            <description>TAK-954 0.2 mg, infusion, intravenously, once on Day 1.</description>
          </group>
          <group group_id="O3">
            <title>Group C, Severe Hepatic Impairment: TAK-954 0.2 mg</title>
            <description>TAK-954 0.2 mg, infusion, intravenously, once on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>AUClast: Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-954 (Total and Free)</title>
          <population>The PK set consisted of all participants who were enrolled and received the correct dose of study drug and had at least 1 measurable plasma concentration or amount of drug in the urine for TAK-954.</population>
          <units>hour*nanogram per milliliter (h*ng/mL)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TAK-954 (Total)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.57" spread="19.2"/>
                    <measurement group_id="O2" value="23.57" spread="26.2"/>
                    <measurement group_id="O3" value="20.19" spread="32.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TAK-954 (Free)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.501" spread="12.0"/>
                    <measurement group_id="O2" value="1.737" spread="23.0"/>
                    <measurement group_id="O3" value="1.898" spread="19.3"/>
                  </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>Other</non_inferiority_type>
            <non_inferiority_desc>TAK-954 (Total): An ANOVA were performed on log transformed AUClast (Total TAK-954) to compare each hepatically impaired group with the normal hepatic function group.</non_inferiority_desc>
            <p_value>0.151</p_value>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>TAK-954 (Total): An ANOVA were performed on log transformed AUClast (Total TAK-954) to compare each hepatically impaired group with the normal hepatic function group.</non_inferiority_desc>
            <p_value>0.017</p_value>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>TAK-954 (Free): An ANOVA were performed on log transformed AUClast (Free TAK-954) to compare each hepatically impaired group with the normal hepatic function group.</non_inferiority_desc>
            <p_value>0.129</p_value>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>TAK-954 (Free): An ANOVA were performed on log transformed AUClast (Free TAK-954) to compare each hepatically impaired group with the normal hepatic function group.</non_inferiority_desc>
            <p_value>0.023</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC∞: Area Under the Concentration-time Curve From Time 0 to Infinity for TAK-954 (Total and Free)</title>
        <time_frame>Day 1 pre-infusion and at multiple time points (up to 96 hours) post-infusion</time_frame>
        <population>The PK set consisted of all participants who were enrolled and received the correct dose of study drug and had at least 1 measurable plasma concentration or amount of drug in the urine for TAK-954.</population>
        <group_list>
          <group group_id="O1">
            <title>Healthy Participants: TAK-954 0.2 mg</title>
            <description>TAK-954 0.2 milligram (mg), infusion, intravenously, once on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Group B, Moderate Hepatic Impairment: TAK-954 0.2 mg</title>
            <description>TAK-954 0.2 mg, infusion, intravenously, once on Day 1.</description>
          </group>
          <group group_id="O3">
            <title>Group C, Severe Hepatic Impairment: TAK-954 0.2 mg</title>
            <description>TAK-954 0.2 mg, infusion, intravenously, once on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>AUC∞: Area Under the Concentration-time Curve From Time 0 to Infinity for TAK-954 (Total and Free)</title>
          <population>The PK set consisted of all participants who were enrolled and received the correct dose of study drug and had at least 1 measurable plasma concentration or amount of drug in the urine for TAK-954.</population>
          <units>h*ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TAK-954 (Total)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.30" spread="20.1"/>
                    <measurement group_id="O2" value="25.44" spread="27.1"/>
                    <measurement group_id="O3" value="22.60" spread="34.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TAK-954 (Free)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.643" spread="13.8"/>
                    <measurement group_id="O2" value="1.875" spread="24.0"/>
                    <measurement group_id="O3" value="2.122" spread="21.8"/>
                  </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>Other</non_inferiority_type>
            <non_inferiority_desc>TAK-954 (Total): An ANOVA were performed on log transformed AUCinf (Total TAK-954) to compare each hepatically impaired group with the normal hepatic function group.</non_inferiority_desc>
            <p_value>0.138</p_value>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>TAK-954 (Total): An ANOVA were performed on log transformed AUCinf (Total TAK-954) to compare each hepatically impaired group with the normal hepatic function group.</non_inferiority_desc>
            <p_value>0.029</p_value>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>TAK-954 (Free): An ANOVA were performed on log transformed AUCinf (Free TAK-954) to compare each hepatically impaired group with the normal hepatic function group.</non_inferiority_desc>
            <p_value>0.201</p_value>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>TAK-954 (Free): An ANOVA were performed on log transformed AUCinf (Free TAK-954) to compare each hepatically impaired group with the normal hepatic function group.</non_inferiority_desc>
            <p_value>0.023</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinically Significant Physical Examination Findings</title>
        <time_frame>Up to 14 days after the last dose of study drug (Day 15)</time_frame>
        <population>The safety set consisted of all participants who were enrolled and received the study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Healthy Participants: TAK-954 0.2 mg</title>
            <description>TAK-954 0.2 milligram (mg), infusion, intravenously, once on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Group B, Moderate Hepatic Impairment: TAK-954 0.2 mg</title>
            <description>TAK-954 0.2 mg, infusion, intravenously, once on Day 1.</description>
          </group>
          <group group_id="O3">
            <title>Group C, Severe Hepatic Impairment: TAK-954 0.2 mg</title>
            <description>TAK-954 0.2 mg, infusion, intravenously, once on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Physical Examination Findings</title>
          <population>The safety set consisted of all participants who were enrolled and received the 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="8"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Markedly Abnormal Electrocardiograms (ECGs)</title>
        <time_frame>Up to 14 days after the last dose of study drug (Day 15)</time_frame>
        <population>The safety set consisted of all participants who were enrolled and received the study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Healthy Participants: TAK-954 0.2 mg</title>
            <description>TAK-954 0.2 milligram (mg), infusion, intravenously, once on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Group B, Moderate Hepatic Impairment: TAK-954 0.2 mg</title>
            <description>TAK-954 0.2 mg, infusion, intravenously, once on Day 1.</description>
          </group>
          <group group_id="O3">
            <title>Group C, Severe Hepatic Impairment: TAK-954 0.2 mg</title>
            <description>TAK-954 0.2 mg, infusion, intravenously, once on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Markedly Abnormal Electrocardiograms (ECGs)</title>
          <population>The safety set consisted of all participants who were enrolled and received the 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="8"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Markedly Abnormal Values of Vital Signs</title>
        <time_frame>Up to 14 days after the last dose of study drug (Day 15)</time_frame>
        <population>The safety set consisted of all participants who were enrolled and received the study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Healthy Participants: TAK-954 0.2 mg</title>
            <description>TAK-954 0.2 milligram (mg), infusion, intravenously, once on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Group B, Moderate Hepatic Impairment: TAK-954 0.2 mg</title>
            <description>TAK-954 0.2 mg, infusion, intravenously, once on Day 1.</description>
          </group>
          <group group_id="O3">
            <title>Group C, Severe Hepatic Impairment: TAK-954 0.2 mg</title>
            <description>TAK-954 0.2 mg, infusion, intravenously, once on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Markedly Abnormal Values of Vital Signs</title>
          <population>The safety set consisted of all participants who were enrolled and received the 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="8"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Values</title>
        <time_frame>Up to 14 days after the last dose of study drug (Day 15)</time_frame>
        <population>The safety set consisted of all participants who were enrolled and received the study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Healthy Participants: TAK-954 0.2 mg</title>
            <description>TAK-954 0.2 milligram (mg), infusion, intravenously, once on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Group B, Moderate Hepatic Impairment: TAK-954 0.2 mg</title>
            <description>TAK-954 0.2 mg, infusion, intravenously, once on Day 1.</description>
          </group>
          <group group_id="O3">
            <title>Group C, Severe Hepatic Impairment: TAK-954 0.2 mg</title>
            <description>TAK-954 0.2 mg, infusion, intravenously, once on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Values</title>
          <population>The safety set consisted of all participants who were enrolled and received the 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="8"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)</title>
        <time_frame>Baseline up to 30 days after last dose of study drug (Day 31)</time_frame>
        <population>The safety set consisted of all participants who were enrolled and received the study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Healthy Participants: TAK-954 0.2 mg</title>
            <description>TAK-954 0.2 milligram (mg), infusion, intravenously, once on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Group B, Moderate Hepatic Impairment: TAK-954 0.2 mg</title>
            <description>TAK-954 0.2 mg, infusion, intravenously, once on Day 1.</description>
          </group>
          <group group_id="O3">
            <title>Group C, Severe Hepatic Impairment: TAK-954 0.2 mg</title>
            <description>TAK-954 0.2 mg, infusion, intravenously, once on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)</title>
          <population>The safety set consisted of all participants who were enrolled and received the 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="8"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (Day 31) after the last dose of study drug</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>Healthy Participants: TAK-954 0.2 mg</title>
          <description>TAK-954 0.2 milligram (mg), infusion, intravenously, once on Day 1.</description>
        </group>
        <group group_id="E2">
          <title>Group B, Moderate Hepatic Impairment: TAK-954 0.2 mg</title>
          <description>TAK-954 0.2 mg, infusion, intravenously, once on Day 1.</description>
        </group>
        <group group_id="E3">
          <title>Group C, Severe Hepatic Impairment: TAK-954 0.2 mg</title>
          <description>TAK-954 0.2 mg, infusion, intravenously, once on Day 1.</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="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 21.0</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="2" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </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/NCT03277274
org study id: TAK-954-1006
secondary id: 2017-000714-37
secondary id: U1111-1196-9190
nct id: NCT03277274
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the effect of varying degrees of hepatic function on
      the single dose PK of IV TAK-954.
The drug being tested in this study is called TAK-954. This study will evaluate the safety
      and tolerability of single intravenous doses of TAK-954 in participants with varying degrees
      of hepatic function.

      The study will enroll approximately up to 32 participants. Participants will be enrolled in
      one of the 4 treatment groups based on their degree of hepatic impairment which will be
      determined based on Child-Pugh Score as follow:

        -  Group 1 TAK-954 0.2 mg: Mild Hepatic Impairment (Child Pugh Class A)

        -  Group 2 TAK-954 0.2 mg: Moderate Hepatic Impairment (Child Pugh Class B)

        -  Group 3 TAK-954 0.2 mg: Severe Hepatic Impairment (Child Pugh Class C)

        -  Group 4 TAK-954 0.2 mg: Healthy Participants

      The Child-Pugh classification will assess the severity of 5 hepatic parameters (total serum
      bilirubin, serum albumin, prothrombin time, ascites and encephalopathy grade) on a scale of 1
      (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe)
      where higher score indicates more severity.

      All participants will receive a single dose of TAK-954 0.2 mg on Day 1.

      This study may have a full study design, where Group 1 to Group 4 will enroll approximately 8
      participants in each group or a reduced study design, where no participants will be enrolled
      in Group 1 and approximately 8 participants will be enrolled in Group 2 to Group 4.

      This multi-center trial will be conducted in Czech Republic and Slovakia. The overall time to
      participate in this study is approximately 7 weeks. Participants will remain confined to the
      clinic for 4 days, with 2 further out-patient visits, and will make a final visit to the
      clinic 10-14 days after receiving their last dose of TAK-954 for a follow-up assessment.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Other
masking: None (Open Label)
measure: Cmax: Maximum Observed Plasma Concentration for TAK-954 (Total and Free)
time frame: Day 1 pre-infusion and at multiple time points (up to 96 hours) post-infusion
measure: AUClast: Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-954 (Total and Free)
time frame: Day 1 pre-infusion and at multiple time points (up to 96 hours) post-infusion
measure: AUC∞: Area Under the Concentration-time Curve From Time 0 to Infinity for TAK-954 (Total and Free)
time frame: Day 1 pre-infusion and at multiple time points (up to 96 hours) post-infusion
measure: Number of Participants With Clinically Significant Physical Examination Findings
time frame: Up to 14 days after the last dose of study drug (Day 15)
measure: Number of Participants With Markedly Abnormal Electrocardiograms (ECGs)
time frame: Up to 14 days after the last dose of study drug (Day 15)
measure: Number of Participants With Markedly Abnormal Values of Vital Signs
time frame: Up to 14 days after the last dose of study drug (Day 15)
measure: Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Values
time frame: Up to 14 days after the last dose of study drug (Day 15)
measure: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
time frame: Baseline up to 30 days after last dose of study drug (Day 31)
arm group label: Group 1 Mild Hepatic Impairment: TAK-954 0.2 mg
arm group type: Experimental
description: TAK-954 0.2 milligram (mg), intravenous, administered as 60-minute infusion, once on Day 1.
arm group label: Group 2 Moderate Hepatic Impairment: TAK-954 0.2 mg
arm group type: Experimental
description: TAK-954 0.2 mg, intravenous, administered as 60-minute infusion, once on Day 1.
arm group label: Group 3 Severe Hepatic Impairment: TAK-954 0.2 mg
arm group type: Experimental
description: TAK-954 0.2 mg, intravenous, administered as 60-minute infusion, once on Day 1.
arm group label: Group 4 Healthy Participants: TAK-954 0.2 mg
arm group type: Experimental
description: TAK-954 0.2 mg, intravenous, administered as 60-minute infusion, once on Day 1.
intervention type: Drug
intervention name: TAK-954
description: TAK-954 intravenous infusion.
arm group label: Group 1 Mild Hepatic Impairment: TAK-954 0.2 mg
arm group label: Group 2 Moderate Hepatic Impairment: TAK-954 0.2 mg
arm group label: Group 3 Severe Hepatic Impairment: TAK-954 0.2 mg
arm group label: Group 4 Healthy Participants: TAK-954 0.2 mg
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Medical Director
role: Study Director
affiliation: Takeda
facility: 
facility: 
country: Czechia
country: Slovakia
responsible party type: Sponsor
mesh term: Liver Diseases
sharing ipd: Yes
ipd description: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 