<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/NCT03289208</url>
  </required_header>
  <id_info>
    <org_study_id>MCI-186-J22</org_study_id>
    <nct_id>NCT03289208</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Renal Impairment</brief_title>
  <official_title>An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of MCI-186 in Subjects With Mild or Moderate Renal Impairment Compared to Subjects With Normal Renal Function</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mitsubishi Tanabe Pharma Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mitsubishi Tanabe Pharma Corporation</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To assess the pharmacokinetics of MCI-186 after a single intravenous infusion of 30mg/hour in&#xD;
      subjects with mild or moderate renal impairment compared to subjects with normal renal&#xD;
      function.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 27, 2016</start_date>
  <completion_date type="Actual">April 20, 2018</completion_date>
  <primary_completion_date type="Actual">April 16, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cmax</measure>
    <time_frame>pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0-last</measure>
    <time_frame>pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0-∞</measure>
    <time_frame>pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>t½</measure>
    <time_frame>pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Renal Impairment</condition>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>mild renal impairment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>moderated renal impairment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>normal renal function</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MCI-186</intervention_name>
    <description>30 mg of edaravone will be administered intravenously over 60 minutes.</description>
    <arm_group_label>mild renal impairment</arm_group_label>
    <arm_group_label>moderated renal impairment</arm_group_label>
    <arm_group_label>normal renal function</arm_group_label>
    <other_name>Edaravone</other_name>
    <other_name>Radicut</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All subjects&#xD;
&#xD;
          -  Able to provide written informed consent to participate in this study after reading&#xD;
             the ICF&#xD;
&#xD;
          -  Subjects is able to understand and willing to cooperate and comply with the Protocol&#xD;
             restrictions and requirements&#xD;
&#xD;
          -  A body weight of ≥45 kg in males or ≥40 kg in females and a body mass index ranging&#xD;
             from 18 to 30 kg/m2&#xD;
&#xD;
        Renal impaired subjects (in addition)&#xD;
&#xD;
          -  Subjects with mild renal impairment defined as eGFR 60-89 mL/min/1.73m2 and subjects&#xD;
             with moderate renal impairment defined as eGFR 30-59 mL/min/1.73m2&#xD;
&#xD;
          -  Chronic and stable renal impairment&#xD;
&#xD;
        Healthy subjects (in addition)&#xD;
&#xD;
          -  Subject with normal renal function defined as eGFR≥90 mL/min/1.73m2&#xD;
&#xD;
          -  Good health and free from clinically significant illness or disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        All subjects&#xD;
&#xD;
          -  Presence or history of severe allergy to food, or any medicinal product or relevant&#xD;
             excipient that is of clinical significance&#xD;
&#xD;
          -  Subjects were previously administered MCI-186&#xD;
&#xD;
          -  Positive urine drug screen (if not due to concomitant medication) or alcohol test&#xD;
&#xD;
          -  History of alcohol abuse or drug abuse&#xD;
&#xD;
          -  Presence of active infection requiring antibiotics&#xD;
&#xD;
          -  Positive test for human immunodeficiency virus (HIV) antigen/antibody, hepatitis B&#xD;
             surface antigen (HBsAg), or hepatitis C virus antibody (HCVAb)&#xD;
&#xD;
        Renal impairment subject (in addition)&#xD;
&#xD;
          -  Acute renal failure&#xD;
&#xD;
          -  History of renal transplantation&#xD;
&#xD;
          -  Aspartate aminotransferase (AST) activity, or an alanine aminotransferase (ALT)&#xD;
             activity of at least 3 times the upper limit of normal (ULN) range&#xD;
&#xD;
          -  Uncontrolled, or untreated hypertension defined as systolic blood pressure (SBP)&gt;180&#xD;
             mmHg and/or diastolic blood pressure (DBP)&gt;110 mmHg&#xD;
&#xD;
          -  Start of any new medication or new any changes to a current dosage&#xD;
&#xD;
        Healthy subject (in addition)&#xD;
&#xD;
          -  History or presence of any renal disease&#xD;
&#xD;
          -  Uncontrolled, or untreated hypertension defined as systolic blood pressure (SBP)&gt;160&#xD;
             mmHg and/or diastolic blood pressure (DBP)&gt;100 mmHg&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>General Manager</last_name>
    <role>Study Director</role>
    <affiliation>Mitsubishi Tanabe Pharma Corporation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Investigational site</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 20, 2017</study_first_posted>
  <results_first_submitted>February 13, 2020</results_first_submitted>
  <results_first_submitted_qc>February 13, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">February 28, 2020</results_first_posted>
  <last_update_submitted>April 3, 2023</last_update_submitted>
  <last_update_submitted_qc>April 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Renal Insufficiency</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Edaravone</mesh_term>
  </intervention_browse>
  <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>April 2, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/08/NCT03289208/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>June 20, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/08/NCT03289208/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Mild Renal Function Group</title>
          <description>Mild renal function defined as eGFR 60-89 mL/min/1.73m^2</description>
        </group>
        <group group_id="P2">
          <title>Moderate Renal Function Group</title>
          <description>Moderate renal function defined as eGFR 30-59 mL/min/1.73m^2</description>
        </group>
        <group group_id="P3">
          <title>Normal Renal Function Group</title>
          <description>Normal renal function defined as eGFR ≥90 mL/min/1.73m^2</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Mild Renal Function Group</title>
          <description>Mild renal function defined as eGFR 60-89 mL/min/1.73m^2</description>
        </group>
        <group group_id="B2">
          <title>Moderate Renal Function Group</title>
          <description>Moderate renal function defined as eGFR 30-59 mL/min/1.73m^2</description>
        </group>
        <group group_id="B3">
          <title>Normal Renal Function Group</title>
          <description>Normal renal function defined as eGFR ≥90 mL/min/1.73m^2</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="11"/>
            <count group_id="B2" value="8"/>
            <count group_id="B3" value="11"/>
            <count group_id="B4" value="30"/>
          </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="35.5" spread="5.1"/>
                    <measurement group_id="B2" value="57.9" spread="8.4"/>
                    <measurement group_id="B3" value="47.3" spread="4.3"/>
                    <measurement group_id="B4" value="45.8" spread="10.6"/>
                  </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="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="21"/>
                  </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="11"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="30"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </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_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Cmax</title>
        <time_frame>pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose</time_frame>
        <population>PK population</population>
        <group_list>
          <group group_id="O1">
            <title>Mild Renal Function Group</title>
            <description>Mild renal function defined as eGFR 60-89 mL/min/1.73m^2</description>
          </group>
          <group group_id="O2">
            <title>Moderate Renal Function Group</title>
            <description>Moderate renal function defined as eGFR 30-59 mL/min/1.73m^2</description>
          </group>
          <group group_id="O3">
            <title>Normal Renal Function Group</title>
            <description>Normal renal function defined as eGFR ≥90 mL/min/1.73m^2</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax</title>
          <population>PK population</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="8"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="545.4" spread="92.59"/>
                    <measurement group_id="O2" value="593.2" spread="115.4"/>
                    <measurement group_id="O3" value="475.9" spread="95.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC0-last</title>
        <time_frame>pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose</time_frame>
        <population>PK population</population>
        <group_list>
          <group group_id="O1">
            <title>Mild Renal Function Group</title>
            <description>Mild renal function defined as eGFR 60-89 mL/min/1.73m^2</description>
          </group>
          <group group_id="O2">
            <title>Moderate Renal Function Group</title>
            <description>Moderate renal function defined as eGFR 30-59 mL/min/1.73m^2</description>
          </group>
          <group group_id="O3">
            <title>Normal Renal Function Group</title>
            <description>Normal renal function defined as eGFR ≥90 mL/min/1.73m^2</description>
          </group>
        </group_list>
        <measure>
          <title>AUC0-last</title>
          <population>PK population</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="8"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="758" spread="148.09"/>
                    <measurement group_id="O2" value="808.7" spread="152.01"/>
                    <measurement group_id="O3" value="638.09" spread="151.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC0-∞</title>
        <time_frame>pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose</time_frame>
        <population>PK population</population>
        <group_list>
          <group group_id="O1">
            <title>Mild Renal Function Group</title>
            <description>Mild renal function defined as eGFR 60-89 mL/min/1.73m^2</description>
          </group>
          <group group_id="O2">
            <title>Moderate Renal Function Group</title>
            <description>Moderate renal function defined as eGFR 30-59 mL/min/1.73m^2</description>
          </group>
          <group group_id="O3">
            <title>Normal Renal Function Group</title>
            <description>Normal renal function defined as eGFR ≥90 mL/min/1.73m^2</description>
          </group>
        </group_list>
        <measure>
          <title>AUC0-∞</title>
          <population>PK population</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="8"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="770.97" spread="153.63"/>
                    <measurement group_id="O2" value="826.44" spread="149.44"/>
                    <measurement group_id="O3" value="644.85" spread="153.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>t½</title>
        <time_frame>pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose</time_frame>
        <population>PK population</population>
        <group_list>
          <group group_id="O1">
            <title>Mild Renal Function Group</title>
            <description>Mild renal function defined as eGFR 60-89 mL/min/1.73m^2</description>
          </group>
          <group group_id="O2">
            <title>Moderate Renal Function Group</title>
            <description>Moderate renal function defined as eGFR 30-59 mL/min/1.73m^2</description>
          </group>
          <group group_id="O3">
            <title>Normal Renal Function Group</title>
            <description>Normal renal function defined as eGFR ≥90 mL/min/1.73m^2</description>
          </group>
        </group_list>
        <measure>
          <title>t½</title>
          <population>PK population</population>
          <units>hour</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.38" spread="6.04"/>
                    <measurement group_id="O2" value="7.31" spread="5.83"/>
                    <measurement group_id="O3" value="2.87" spread="0.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>7 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Mild Renal Function Group</title>
          <description>Mild renal function defined as eGFR 60-89 mL/min/1.73m^2</description>
        </group>
        <group group_id="E2">
          <title>Moderate Renal Function Group</title>
          <description>Moderate renal function defined as eGFR 30-59 mL/min/1.73m^2</description>
        </group>
        <group group_id="E3">
          <title>Normal Renal Function Group</title>
          <description>Normal renal function defined as eGFR ≥90 mL/min/1.73m^2</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA/J version20.0</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="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Vomitting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
              </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="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Trials, Information Desk</name_or_title>
      <organization>Mitsubishi Tanabe Pharma Corporation</organization>
      <phone>Please Email</phone>
      <email>cti-inq-ml@ml.mt-pharma.co.jp</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/NCT03289208
org study id: MCI-186-J22
nct id: NCT03289208
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To assess the pharmacokinetics of MCI-186 after a single intravenous infusion of 30mg/hour in
      subjects with mild or moderate renal impairment compared to subjects with normal renal
      function.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Cmax
time frame: pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose
measure: AUC0-last
time frame: pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose
measure: AUC0-∞
time frame: pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose
measure: t½
time frame: pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose
arm group label: mild renal impairment
arm group type: Experimental
arm group label: moderated renal impairment
arm group type: Experimental
arm group label: normal renal function
arm group type: Experimental
intervention type: Drug
intervention name: MCI-186
description: 30 mg of edaravone will be administered intravenously over 60 minutes.
arm group label: mild renal impairment
arm group label: moderated renal impairment
arm group label: normal renal function
other name: Edaravone
other name: Radicut
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: General Manager
role: Study Director
affiliation: Mitsubishi Tanabe Pharma Corporation
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Renal Insufficiency
mesh term: Edaravone
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 