<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/NCT01732263</url>
  </required_header>
  <id_info>
    <org_study_id>SPD602-105</org_study_id>
    <nct_id>NCT01732263</nct_id>
  </id_info>
  <brief_title>Study of SSP-004184 (SPD602) in Healthy Adults and Subjects With Impaired Liver Function</brief_title>
  <official_title>A Phase 1, Open-label, Single-dose Study of the Pharmacokinetics, Safety, and Tolerability of SSP-004184 (SPD602) in Subjects With Hepatic Impairment Compared to Matched Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shire</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Takeda</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate how much of the study drug SSP-004184 (SPD602) is&#xD;
      absorbed by the body and how long it takes to be eliminated from the body in healthy subjects&#xD;
      and subjects with mild, moderate, and severe hepatic (liver) impairment compared with&#xD;
      subjects with healthy normal liver function.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 9, 2012</start_date>
  <completion_date type="Actual">April 1, 2013</completion_date>
  <primary_completion_date type="Actual">April 1, 2013</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area Under the Plasma Concentration-time Curve (AUC) of SSP-004184</measure>
    <time_frame>Over 96 hours post-dose</time_frame>
    <description>AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Plasma Concentration (Cmax) of SSP-004184</measure>
    <time_frame>Over 96 hours post-dose</time_frame>
    <description>Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time of Maximum Plasma Concentration (Tmax) for SSP-004184</measure>
    <time_frame>Over 96 hours post-dose</time_frame>
    <description>Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma Half-Life (T 1/2) of SSP-004184</measure>
    <time_frame>Over 96 hours post-dose</time_frame>
    <description>The time it takes for the blood plasma concentration of a substance to halve.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total Body Clearance (CL/F) of SSP-004184</measure>
    <time_frame>Over 96 hours post-dose</time_frame>
    <description>The rate at which a drug is removed from the body.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Volume of Distribution (Vz/F) of SSP-004184</measure>
    <time_frame>Over 96 hours post-dose</time_frame>
    <description>The distribution of a medication between plasma and the rest of the body.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Hepatic Impairment</condition>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>SSP-004184 (Child-Pugh A Liver Impaired)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SSP-004184 (Child-Pugh B Liver Impaired)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>SSP-004184 (Child-Pugh C Liver Impaired)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>SSP-004184 (Matched Healthy Subjects)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SSP-004184</intervention_name>
    <description>All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1</description>
    <arm_group_label>SSP-004184 (Child-Pugh A Liver Impaired)</arm_group_label>
    <arm_group_label>SSP-004184 (Child-Pugh B Liver Impaired)</arm_group_label>
    <arm_group_label>SSP-004184 (Child-Pugh C Liver Impaired)</arm_group_label>
    <arm_group_label>SSP-004184 (Matched Healthy Subjects)</arm_group_label>
    <other_name>SPD602, FBS0701</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-65 years inclusive at the time of consent.&#xD;
&#xD;
          -  Willingness to comply with any applicable contraceptive requirements of the protocol&#xD;
             and is:&#xD;
&#xD;
          -  Male, or&#xD;
&#xD;
          -  Non pregnant, non lactating female&#xD;
&#xD;
          -  Females must be at least 90 days post partum or nulliparous.&#xD;
&#xD;
        Subjects who do not have hepatic impairment (healthy subjects)&#xD;
&#xD;
          -  Normal renal function.&#xD;
&#xD;
        Subjects with hepatic impairment&#xD;
&#xD;
          -  Subjects must provide a letter of evaluation from a hepatologist or copy of supporting&#xD;
             documents confirming the subject's hepatic impairment (a liver biopsy is preferable&#xD;
             but not mandatory).&#xD;
&#xD;
          -  Hepatic impairment should be primary and must not be a complication of an underlying&#xD;
             primary systemic disease (eg, patients with metastatic cancer and cancer cachexia)&#xD;
&#xD;
          -  Documented chronic stable liver impairment&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
        Subjects who do not have hepatic impairment (healthy subjects)&#xD;
&#xD;
          -  A positive HIV antibody screen, Hepatitis B surface antigen, or Hepatitis C virus&#xD;
             antibody screen.&#xD;
&#xD;
        Subjects with hepatic impairment&#xD;
&#xD;
          -  Presence of a hepatocellular carcinoma, or an acute hepatic disease caused by an&#xD;
             infection or drug toxicity.&#xD;
&#xD;
          -  Presence of surgically created or transjugular intrahepatic portal systemic shunts.&#xD;
&#xD;
          -  A positive HIV antibody screen.&#xD;
&#xD;
          -  Renal insufficiency.&#xD;
&#xD;
        All subjects&#xD;
&#xD;
          -  Subject has a history of thyroid disorder.&#xD;
&#xD;
          -  History of nephrotic syndrome.&#xD;
&#xD;
          -  History of alcohol or other substance abuse within the last year.&#xD;
&#xD;
          -  A positive screen for alcohol or drugs of abuse.&#xD;
&#xD;
          -  Male subjects who consume more than 3 units of alcohol per day. Female subjects who&#xD;
             consume more than 2 units of alcohol per day. (1 alcohol unit = 1 beer [12 oz/355 mL]&#xD;
             = 1 wine [5 oz/150 mL] = 1 liquor [1.5 oz/40 mL] = 0.75 oz/20 mL alcohol.)&#xD;
&#xD;
          -  Caffeine consumption: For healthy subjects: Routine consumption of more than 2 units&#xD;
             of caffeine per day or subjects who experience caffeine withdrawal headaches or have a&#xD;
             history of caffeine withdrawal headaches. (One caffeine unit is contained in the&#xD;
             following items: one 6 oz/180 mL cup of coffee, two 12 oz/355 mL (ie, 24 oz/710 mL&#xD;
             cola) cans of cola, one 12 oz/355 mL cup of tea, three 1 oz/28 g chocolate bars (ie, 3&#xD;
             oz/85 g chocolate). Decaffeinated coffee, tea, or cola are not considered to contain&#xD;
             caffeine.)&#xD;
&#xD;
          -  Donation of blood or blood products within 60 days.&#xD;
&#xD;
          -  Substantial changes in eating habits within 30 days.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Takeda</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Pharmacology of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orlando Clinical Research Center (OCRC)</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32809</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>November 19, 2012</study_first_submitted>
  <study_first_submitted_qc>November 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2012</study_first_posted>
  <results_first_submitted>April 16, 2014</results_first_submitted>
  <results_first_submitted_qc>April 16, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">May 15, 2014</results_first_posted>
  <last_update_submitted>June 22, 2021</last_update_submitted>
  <last_update_submitted_qc>June 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2021</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>Liver Diseases</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>One subject withdrew from study prior to randomization (n = 43).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Hepatic Impairment</title>
          <description>All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).</description>
        </group>
        <group group_id="P2">
          <title>Matched Healthy Subjects</title>
          <description>All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Hepatic Impairment</title>
          <description>All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).</description>
        </group>
        <group group_id="B2">
          <title>Matched Healthy Subjects</title>
          <description>All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).</description>
        </group>
        <group group_id="B3">
          <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="23"/>
            <count group_id="B2" value="20"/>
            <count group_id="B3" value="43"/>
          </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="56.3" spread="5.13"/>
                    <measurement group_id="B2" value="55.1" spread="5.51"/>
                    <measurement group_id="B3" value="55.7" spread="5.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>&gt;=65 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Between 18 and 65 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="42"/>
                  </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="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>UNITED STATES</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Plasma Concentration-time Curve (AUC) of SSP-004184</title>
        <description>AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.</description>
        <time_frame>Over 96 hours post-dose</time_frame>
        <population>Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set consists of all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>SSP-004184 (Child-Pugh A Liver Impaired) 50 mg/kg</title>
            <description>The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis. All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).</description>
          </group>
          <group group_id="O2">
            <title>SSP-004184 (Child-Pugh B Liver Impaired) 45 mg/kg</title>
            <description>The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis. All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).</description>
          </group>
          <group group_id="O3">
            <title>SSP-004184 (Child-Pugh B Liver Impaired) 50 mg/kg</title>
            <description>The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis. All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).</description>
          </group>
          <group group_id="O4">
            <title>SSP-004184 (Child-Pugh C Liver Impaired) 45 mg/kg</title>
            <description>The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis. All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).</description>
          </group>
          <group group_id="O5">
            <title>SSP-004184 (Matched Healthy Subjects) 45 mg/kg</title>
            <description>All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).</description>
          </group>
          <group group_id="O6">
            <title>SSP-004184 (Matched Healthy Subjects) 50 mg/kg</title>
            <description>All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Plasma Concentration-time Curve (AUC) of SSP-004184</title>
          <description>AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.</description>
          <population>Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set consists of all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.</population>
          <units>ng*h/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="8"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="10"/>
                <count group_id="O6" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="254327.7" spread="57645.3"/>
                    <measurement group_id="O2" value="443053.5" spread="157352.1"/>
                    <measurement group_id="O3" value="288579.6" spread="149123.5"/>
                    <measurement group_id="O4" value="410414.3" spread="111201.8"/>
                    <measurement group_id="O5" value="209989.8" spread="83155.2"/>
                    <measurement group_id="O6" value="310281.3" spread="112004.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Maximum Plasma Concentration (Cmax) of SSP-004184</title>
        <description>Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.</description>
        <time_frame>Over 96 hours post-dose</time_frame>
        <population>Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set consists of all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>SSP-004184 (Child-Pugh A Liver Impaired) 50 mg/kg</title>
            <description>The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis. All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).</description>
          </group>
          <group group_id="O2">
            <title>SSP-004184 (Child-Pugh B Liver Impaired) 45 mg/kg</title>
            <description>The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis. All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).</description>
          </group>
          <group group_id="O3">
            <title>SSP-004184 (Child-Pugh B Liver Impaired) 50 mg/kg</title>
            <description>The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis. All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).</description>
          </group>
          <group group_id="O4">
            <title>SSP-004184 (Child-Pugh C Liver Impaired) 45 mg/kg</title>
            <description>The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis. All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).</description>
          </group>
          <group group_id="O5">
            <title>SSP-004184 (Matched Healthy Subjects) 45 mg/kg</title>
            <description>All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).</description>
          </group>
          <group group_id="O6">
            <title>SSP-004184 (Matched Healthy Subjects) 50 mg/kg</title>
            <description>All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Plasma Concentration (Cmax) of SSP-004184</title>
          <description>Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.</description>
          <population>Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set consists of all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.</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="8"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="10"/>
                <count group_id="O6" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98887.5" spread="29689.1"/>
                    <measurement group_id="O2" value="121460.0" spread="28777.7"/>
                    <measurement group_id="O3" value="109166.7" spread="52920.5"/>
                    <measurement group_id="O4" value="123985.0" spread="34807.1"/>
                    <measurement group_id="O5" value="83350.0" spread="28538.1"/>
                    <measurement group_id="O6" value="108890.0" spread="41016.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Time of Maximum Plasma Concentration (Tmax) for SSP-004184</title>
        <description>Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.</description>
        <time_frame>Over 96 hours post-dose</time_frame>
        <population>Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set consists of all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>SSP-004184 (Child-Pugh A Liver Impaired) 50 mg/kg</title>
            <description>The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis. All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).</description>
          </group>
          <group group_id="O2">
            <title>SSP-004184 (Child-Pugh B Liver Impaired) 45 mg/kg</title>
            <description>The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis. All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).</description>
          </group>
          <group group_id="O3">
            <title>SSP-004184 (Child-Pugh B Liver Impaired) 50 mg/kg</title>
            <description>The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis. All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).</description>
          </group>
          <group group_id="O4">
            <title>SSP-004184 (Child-Pugh C Liver Impaired) 45 mg/kg</title>
            <description>The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis. All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).</description>
          </group>
          <group group_id="O5">
            <title>SSP-004184 (Matched Healthy Subjects) 45 mg/kg</title>
            <description>All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).</description>
          </group>
          <group group_id="O6">
            <title>SSP-004184 (Matched Healthy Subjects) 50 mg/kg</title>
            <description>All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).</description>
          </group>
        </group_list>
        <measure>
          <title>Time of Maximum Plasma Concentration (Tmax) for SSP-004184</title>
          <description>Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.</description>
          <population>Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set consists of all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="10"/>
                <count group_id="O6" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" lower_limit="1.0" upper_limit="1.5"/>
                    <measurement group_id="O2" value="1.5" lower_limit="1.0" upper_limit="2.5"/>
                    <measurement group_id="O3" value="1.5" lower_limit="1.0" upper_limit="1.5"/>
                    <measurement group_id="O4" value="1.5" lower_limit="1.0" upper_limit="2.5"/>
                    <measurement group_id="O5" value="1.0" lower_limit="1.0" upper_limit="1.5"/>
                    <measurement group_id="O6" value="1.0" lower_limit="1.0" upper_limit="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Plasma Half-Life (T 1/2) of SSP-004184</title>
        <description>The time it takes for the blood plasma concentration of a substance to halve.</description>
        <time_frame>Over 96 hours post-dose</time_frame>
        <population>Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set consists of all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>SSP-004184 (Child-Pugh A Liver Impaired) 50 mg/kg</title>
            <description>The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis. All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).</description>
          </group>
          <group group_id="O2">
            <title>SSP-004184 (Child-Pugh B Liver Impaired) 45 mg/kg</title>
            <description>The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis. All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).</description>
          </group>
          <group group_id="O3">
            <title>SSP-004184 (Child-Pugh B Liver Impaired) 50 mg/kg</title>
            <description>The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis. All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).</description>
          </group>
          <group group_id="O4">
            <title>SSP-004184 (Child-Pugh C Liver Impaired) 45 mg/kg</title>
            <description>The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis. All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).</description>
          </group>
          <group group_id="O5">
            <title>SSP-004184 (Matched Healthy Subjects) 45 mg/kg</title>
            <description>All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).</description>
          </group>
          <group group_id="O6">
            <title>SSP-004184 (Matched Healthy Subjects) 50 mg/kg</title>
            <description>All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Half-Life (T 1/2) of SSP-004184</title>
          <description>The time it takes for the blood plasma concentration of a substance to halve.</description>
          <population>Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set consists of all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.</population>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="10"/>
                <count group_id="O6" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.91" spread="17.54"/>
                    <measurement group_id="O2" value="11.37" spread="6.47"/>
                    <measurement group_id="O3" value="6.93" spread="0.94"/>
                    <measurement group_id="O4" value="6.79" spread="3.97"/>
                    <measurement group_id="O5" value="12.51" spread="4.51"/>
                    <measurement group_id="O6" value="16.19" spread="8.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Total Body Clearance (CL/F) of SSP-004184</title>
        <description>The rate at which a drug is removed from the body.</description>
        <time_frame>Over 96 hours post-dose</time_frame>
        <population>Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set consists of all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>SSP-004184 (Child-Pugh A Liver Impaired) 50 mg/kg</title>
            <description>The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis. All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).</description>
          </group>
          <group group_id="O2">
            <title>SSP-004184 (Child-Pugh B Liver Impaired) 45 mg/kg</title>
            <description>The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis. All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).</description>
          </group>
          <group group_id="O3">
            <title>SSP-004184 (Child-Pugh B Liver Impaired) 50 mg/kg</title>
            <description>The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis. All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).</description>
          </group>
          <group group_id="O4">
            <title>SSP-004184 (Child-Pugh C Liver Impaired) 45 mg/kg</title>
            <description>The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis. All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).</description>
          </group>
          <group group_id="O5">
            <title>SSP-004184 (Matched Healthy Subjects) 45 mg/kg</title>
            <description>All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).</description>
          </group>
          <group group_id="O6">
            <title>SSP-004184 (Matched Healthy Subjects) 50 mg/kg</title>
            <description>All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).</description>
          </group>
        </group_list>
        <measure>
          <title>Total Body Clearance (CL/F) of SSP-004184</title>
          <description>The rate at which a drug is removed from the body.</description>
          <population>Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set consists of all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.</population>
          <units>L/h/kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="10"/>
                <count group_id="O6" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.204" spread="0.042"/>
                    <measurement group_id="O2" value="0.110" spread="0.035"/>
                    <measurement group_id="O3" value="0.198" spread="0.099"/>
                    <measurement group_id="O4" value="0.119" spread="0.047"/>
                    <measurement group_id="O5" value="0.246" spread="0.097"/>
                    <measurement group_id="O6" value="0.182" spread="0.072"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Volume of Distribution (Vz/F) of SSP-004184</title>
        <description>The distribution of a medication between plasma and the rest of the body.</description>
        <time_frame>Over 96 hours post-dose</time_frame>
        <population>Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set consists of all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>SSP-004184 (Child-Pugh A Liver Impaired) 50 mg/kg</title>
            <description>The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis. All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).</description>
          </group>
          <group group_id="O2">
            <title>SSP-004184 (Child-Pugh B Liver Impaired) 45 mg/kg</title>
            <description>The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis. All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).</description>
          </group>
          <group group_id="O3">
            <title>SSP-004184 (Child-Pugh B Liver Impaired) 50 mg/kg</title>
            <description>The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis. All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).</description>
          </group>
          <group group_id="O4">
            <title>SSP-004184 (Child-Pugh C Liver Impaired) 45 mg/kg</title>
            <description>The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis. All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).</description>
          </group>
          <group group_id="O5">
            <title>SSP-004184 (Matched Healthy Subjects) 45 mg/kg</title>
            <description>All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).</description>
          </group>
          <group group_id="O6">
            <title>SSP-004184 (Matched Healthy Subjects) 50 mg/kg</title>
            <description>All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).</description>
          </group>
        </group_list>
        <measure>
          <title>Volume of Distribution (Vz/F) of SSP-004184</title>
          <description>The distribution of a medication between plasma and the rest of the body.</description>
          <population>Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set consists of all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.</population>
          <units>L/kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="10"/>
                <count group_id="O6" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.344" spread="5.276"/>
                    <measurement group_id="O2" value="1.796" spread="1.210"/>
                    <measurement group_id="O3" value="2.043" spread="1.259"/>
                    <measurement group_id="O4" value="1.370" spread="1.539"/>
                    <measurement group_id="O5" value="4.103" spread="1.420"/>
                    <measurement group_id="O6" value="4.086" spread="2.237"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Hepatic Impairment</title>
        </group>
        <group group_id="E2">
          <title>Matched Healthy Subjects</title>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Chromaturia</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="23"/>
                <counts group_id="E2" events="17" subjects_affected="17" subjects_at_risk="20"/>
              </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>If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>Shire</organization>
      <phone>+1 866 842 5335</phone>
      <email>ClinicalTransparency@shire.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/NCT01732263
org study id: SPD602-105
nct id: NCT01732263
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate how much of the study drug SSP-004184 (SPD602) is
      absorbed by the body and how long it takes to be eliminated from the body in healthy subjects
      and subjects with mild, moderate, and severe hepatic (liver) impairment compared with
      subjects with healthy normal liver function.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Area Under the Plasma Concentration-time Curve (AUC) of SSP-004184
time frame: Over 96 hours post-dose
description: AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
measure: Maximum Plasma Concentration (Cmax) of SSP-004184
time frame: Over 96 hours post-dose
description: Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
measure: Time of Maximum Plasma Concentration (Tmax) for SSP-004184
time frame: Over 96 hours post-dose
description: Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.
measure: Plasma Half-Life (T 1/2) of SSP-004184
time frame: Over 96 hours post-dose
description: The time it takes for the blood plasma concentration of a substance to halve.
measure: Total Body Clearance (CL/F) of SSP-004184
time frame: Over 96 hours post-dose
description: The rate at which a drug is removed from the body.
measure: Volume of Distribution (Vz/F) of SSP-004184
time frame: Over 96 hours post-dose
description: The distribution of a medication between plasma and the rest of the body.
arm group label: SSP-004184 (Child-Pugh A Liver Impaired)
arm group type: Experimental
description: The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
arm group label: SSP-004184 (Child-Pugh B Liver Impaired)
arm group type: Experimental
arm group label: SSP-004184 (Child-Pugh C Liver Impaired)
arm group type: Experimental
arm group label: SSP-004184 (Matched Healthy Subjects)
arm group type: Experimental
intervention type: Drug
intervention name: SSP-004184
description: All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1
arm group label: SSP-004184 (Child-Pugh A Liver Impaired)
arm group label: SSP-004184 (Child-Pugh B Liver Impaired)
arm group label: SSP-004184 (Child-Pugh C Liver Impaired)
arm group label: SSP-004184 (Matched Healthy Subjects)
other name: SPD602, FBS0701
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Study Director
role: Study Director
affiliation: Takeda
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Liver Diseases
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 