<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/NCT01716455</url>
  </required_header>
  <id_info>
    <org_study_id>SPD602-104</org_study_id>
    <nct_id>NCT01716455</nct_id>
  </id_info>
  <brief_title>Study of SSP-004184 (FBS0701) in Healthy Adults and Elderly Subjects and in Subjects With Impaired Renal Function</brief_title>
  <official_title>A Phase 1, Open-label, Single-dose Study of the Pharmacokinetics, Safety, and Tolerability of SSP-004184 (FBS0701) in Healthy Adults and Elderly Subjects and in Subjects With Impaired Renal Function</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>
      Shire is developing SSP-004184 (FBS0701), a novel iron chelator , for the treatment of&#xD;
      chronic iron overload in patients with transfusion-dependent hereditary and acquired anemias.&#xD;
      The primary purpose of the study is to assess the pharmacokinetics of SSP-004184 (FBS0701)&#xD;
      following a single 75mg/kg dose of SSP-004184 (FBS0701) in healthy adults and elderly&#xD;
      subjects and in adult subjects with mild, moderate, severe, and end stage renal disease&#xD;
      (ESRD) degrees of impaired renal function. The results of this study will characterize the&#xD;
      pharmacokinetics, safety, and tolerability of SSP-004184 (FBS0701) in adult subjects with&#xD;
      various degrees of renal impairment, and these data will be compared to healthy adult and&#xD;
      elderly subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 29, 2012</start_date>
  <completion_date type="Actual">March 10, 2013</completion_date>
  <primary_completion_date type="Actual">March 10, 2013</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>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>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Impaired Renal Function</condition>
  <arm_group>
    <arm_group_label>SSP-004184 (Mild Renal Impairment)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subjects will take a single dose of SSP-004184 (75 mg/kg, oral capsule) on Day 1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SSP-004184 (Moderate Renal Impairment)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subjects will take a single dose of SSP-004184 (75 mg/kg, oral capsule) on Day 1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SSP-004184 (Severe Renal Impairment)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subjects will take a single dose of SSP-004184 (75 mg/kg, oral capsule) on Day 1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SSP-004184 (End Stage Renal Disease)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subjects will take a single dose of SSP-004184 (75 mg/kg, oral capsule) on Day 1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SSP-004184 (Healthy Elderly Subjects)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subjects will take a single dose of SSP-004184 (75 mg/kg, oral capsule) on Day 1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SSP-004184 (Matched Healthy Subjects)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subjects will take a single dose of SSP-004184 (75 mg/kg, oral capsule) on Day 1. Healthy subjects matched to renally impaired subjects in arms 1 through 4. (Note: One healthy subject can match more than one renally impaired subject.)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SSP-004184</intervention_name>
    <arm_group_label>SSP-004184 (End Stage Renal Disease)</arm_group_label>
    <arm_group_label>SSP-004184 (Healthy Elderly Subjects)</arm_group_label>
    <arm_group_label>SSP-004184 (Matched Healthy Subjects)</arm_group_label>
    <arm_group_label>SSP-004184 (Mild Renal Impairment)</arm_group_label>
    <arm_group_label>SSP-004184 (Moderate Renal Impairment)</arm_group_label>
    <arm_group_label>SSP-004184 (Severe Renal Impairment)</arm_group_label>
    <other_name>SPD602, FBS0701</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Healthy subjects&#xD;
&#xD;
          -  Age 18-85 years inclusive at the time of consent. The elderly treatment group will be&#xD;
             defined by an age over 65 years. It is required that at least 4 of the subjects in the&#xD;
             elderly group will be over 75 years old.&#xD;
&#xD;
          -  All subjects will be &quot;healthy&quot;&#xD;
&#xD;
          -  Normal renal function (in 18-65 year-old subjects), defined as an estimated glomerular&#xD;
             filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study of&#xD;
             &gt;90 mL/min/ 1.73 m2 at the Screening Visit.&#xD;
&#xD;
          -  The stability of renal function will be confirmed by 2 determinations of serum&#xD;
             creatinine separated by at least 7 days&#xD;
&#xD;
        Subjects with renal impairment&#xD;
&#xD;
          -  Age 18-85 years inclusive at the time of consent.&#xD;
&#xD;
          -  Estimated glomerular filtration rate from the MDRD Study is to be estimated at the&#xD;
             Screening Visit and should be as described in FDA guidance.&#xD;
&#xD;
          -  Subjects must have no clinically significant abnormalities (except for abnormalities&#xD;
             explained by the renal impairment disorder).&#xD;
&#xD;
        All subjects&#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;
          -  An understanding, ability, and willingness to fully comply with study procedures and&#xD;
             restrictions.&#xD;
&#xD;
          -  Ability to provide written, personally signed, and dated informed consent to&#xD;
             participate in the study, in accordance with International Conference on Harmonisation&#xD;
             (ICH) Good Clinical Practice (GCP) Guideline E6 (1996) and applicable regulations,&#xD;
             before completing any study related procedures. The date of signing informed consent&#xD;
             is defined as the beginning of the Screening Period&#xD;
&#xD;
          -  Body mass index between 18.5-40.0 kg/m² inclusive. This inclusion criterion will only&#xD;
             be assessed at the Screening Visit.&#xD;
&#xD;
          -  Hemoglobin of 9.0 g/dL or greater at the Screening Visit and Day -2.&#xD;
&#xD;
          -  No clinically significant deviations from the reference ranges for clinical laboratory&#xD;
             tests as evaluated by the investigator. Low-density lipoprotein cholesterol value must&#xD;
             be &lt;189 mg/dL and triglycerides value must be &lt;499 mg/dL at the Screening Visit.&#xD;
&#xD;
          -  Ability to swallow a dose of investigational product.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Healthy subjects&#xD;
&#xD;
          -  Subject has a clinically significant history or a disorder detected during the medical&#xD;
             interview/physical examination&#xD;
&#xD;
          -  Current or relevant previous history of serious, severe or unstable (acute or&#xD;
             progressive) physical or psychiatric illness, any medical disorder that may require&#xD;
             treatment or make the subject unlikely to fully complete the study, or any condition&#xD;
             that presents undue risk from the investigational product or procedures.&#xD;
&#xD;
          -  History of diabetes mellitus, nephrotic syndrome (defined as plasma albumin &lt;30 g/dL&#xD;
             and/or proteinuria &gt;3 g/day), or other metabolic endocrine disease known to be&#xD;
             associated with alterations in plasma lipid levels. Uncontrolled hypothyroidism is&#xD;
             defined as thyroid stimulating hormone (TSH) 1.5 times greater than the upper limit of&#xD;
             normal (ULN).&#xD;
&#xD;
        Subjects with renal impairment&#xD;
&#xD;
          -  Current or recurrent disease, other than impaired renal function that could affect,&#xD;
             the action, absorption or disposition of the investigational product, or clinical or&#xD;
             laboratory assessments.&#xD;
&#xD;
          -  Concurrent chronic or acute illness or unstable medical condition (other than those&#xD;
             associated with their renal disease) that may deteriorate and thus confound the&#xD;
             results of safety assessments, increase risk to the subject or lead to difficulty&#xD;
             complying with the protocol.&#xD;
&#xD;
          -  A potassium concentration &gt;6.2 mmol/L at the Screening Visit.&#xD;
&#xD;
          -  Subjects with a renal transplant.&#xD;
&#xD;
          -  History of nephrotic syndrome (defined as plasma albumin &lt;30 g/dL and/or proteinuria&#xD;
             &gt;3 g/day), or other metabolic endocrine disease known to be associated with&#xD;
             alterations in plasma lipid levels (uncontrolled hypothyroidism defined as TSH 1.5&#xD;
             times greater than the upper reference range value).&#xD;
&#xD;
          -  Subjects on peritoneal dialysis.&#xD;
&#xD;
          -  Uncontrolled systolic or diastolic blood pressure as defined by the investigator.&#xD;
&#xD;
          -  Liver enzymes (ALT, AST, GGT) more than 2 fold above ULN at the Screening Visit or on&#xD;
             Day -2.&#xD;
&#xD;
          -  Uncontrolled diabetes mellitus as determined by the investigator.&#xD;
&#xD;
          -  Congestive Heart Failure classified New York Heart Association (NYHA) Class III or IV.&#xD;
&#xD;
          -  Any major illness that would in the opinion of the investigator put study subject at&#xD;
             risk or interfere with study conduct.&#xD;
&#xD;
        All subjects&#xD;
&#xD;
          -  Acute illness, as judged by the investigator, within 2 weeks of the first dose of&#xD;
             investigational product.&#xD;
&#xD;
          -  Known or suspected intolerance or hypersensitivity to the investigational products,&#xD;
             closely related compounds, or any of the stated ingredients.&#xD;
&#xD;
          -  Subject has a history of thyroid disorder that has not been stabilized on thyroid&#xD;
             medication or treatment within 3 months of the Screening Visit.&#xD;
&#xD;
          -  History of alcohol or other substance abuse within the last year.&#xD;
&#xD;
          -  A positive screen for alcohol or drugs of abuse at the Screening Visit or on Day -2.&#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. One alcohol unit=1 beer (12 oz/355 mL) =&#xD;
             1 wine (5 oz/150 mL) = 1 liquor (1.5 oz/40 mL)&#xD;
&#xD;
          -  A positive human immunodeficiency virus (HIV) antibody screen, Hepatitis B surface&#xD;
             antigen (HBsAg), or Hepatitis C virus (HCV) antibody screen.&#xD;
&#xD;
          -  Current use of any other medication (including over-the-counter, herbal or homeopathic&#xD;
             preparations) that could affect (improve or worsen) the condition being studied, or&#xD;
             could affect the action, absorption, or disposition of the investigational product(s),&#xD;
             or clinical or laboratory assessment. (Current use is defined as use within 14 days of&#xD;
             dosing). Subjects must be on a stable dose of allowed medications for 14 days prior to&#xD;
             dosing.&#xD;
&#xD;
          -  Use of tobacco in any form (eg, smoking or chewing) or other nicotine-containing&#xD;
             products in any form (eg, gum, patch) within 30 days prior to the first dose of&#xD;
             investigational product.&#xD;
&#xD;
          -  Routine consumption of more than 2 units of caffeine per day or subjects who&#xD;
             experience caffeine withdrawal headaches or have a history of caffeine withdrawal&#xD;
             headaches. (One caffeine unit is contained in the following items: one 6oz/180mL cup&#xD;
             of coffee, two 12 oz/355 mL cans of cola, one 12 oz/355 mL cup of tea, three 1oz/28g&#xD;
             chocolate bars. Decaffeinated coffee, tea, or cola are not considered to contain&#xD;
             caffeine).&#xD;
&#xD;
          -  Donation of blood or blood products (eg, plasma or platelets) within 60 days prior to&#xD;
             the first dose of investigational product.&#xD;
&#xD;
          -  Use of another investigational product within 30 days prior to receiving the first&#xD;
             dose of investigational product or active enrollment in another drug or vaccine&#xD;
             clinical study.&#xD;
&#xD;
          -  Substantial changes in eating habits within 30 days prior to receiving the first dose&#xD;
             of investigational product, as assessed by the investigator.&#xD;
&#xD;
          -  An inability to follow a standardized diet and meal schedule or inability to fast, as&#xD;
             required during the study.&#xD;
&#xD;
          -  Prior screen failure, randomization, participation, or enrollment in this study.&#xD;
&#xD;
          -  Any known hypersensitivity to iohexol or to iodine per se.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 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>May 2021</verification_date>
  <study_first_submitted>October 25, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <results_first_submitted>January 2, 2014</results_first_submitted>
  <results_first_submitted_qc>January 2, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">February 19, 2014</results_first_posted>
  <last_update_submitted>May 29, 2021</last_update_submitted>
  <last_update_submitted_qc>May 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 10, 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>Renal Insufficiency</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>SSP-004184 (Mild Renal Impairment)</title>
          <description>All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1</description>
        </group>
        <group group_id="P2">
          <title>SSP-004184 (Moderate Renal Impairment)</title>
          <description>All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1</description>
        </group>
        <group group_id="P3">
          <title>SSP-004184 (Severe Renal Impairment)</title>
          <description>All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1</description>
        </group>
        <group group_id="P4">
          <title>SSP-004184 (End Stage Renal Disease)</title>
          <description>All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1</description>
        </group>
        <group group_id="P5">
          <title>SSP-004184 (Matched Healthy Subjects)</title>
          <description>All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1</description>
        </group>
        <group group_id="P6">
          <title>SSP-004184 (Healthy Elderly Subjects)</title>
          <description>All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="8"/>
                <participants group_id="P5" count="26"/>
                <participants group_id="P6" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="8"/>
                <participants group_id="P5" count="26"/>
                <participants group_id="P6" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>SSP-004184 (Mild Renal Impairment)</title>
          <description>All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1</description>
        </group>
        <group group_id="B2">
          <title>SSP-004184 (Moderate Renal Impairment)</title>
          <description>All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1</description>
        </group>
        <group group_id="B3">
          <title>SSP-004184 (Severe Renal Impairment)</title>
          <description>All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1</description>
        </group>
        <group group_id="B4">
          <title>SSP-004184 (End Stage Renal Disease)</title>
          <description>All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1</description>
        </group>
        <group group_id="B5">
          <title>SSP-004184 (Matched Healthy Subjects)</title>
          <description>All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1</description>
        </group>
        <group group_id="B6">
          <title>SSP-004184 (Healthy Elderly Subjects)</title>
          <description>All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1</description>
        </group>
        <group group_id="B7">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="8"/>
            <count group_id="B2" value="8"/>
            <count group_id="B3" value="8"/>
            <count group_id="B4" value="8"/>
            <count group_id="B5" value="26"/>
            <count group_id="B6" value="8"/>
            <count group_id="B7" value="66"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58.6" spread="4.47"/>
                    <measurement group_id="B2" value="63.4" spread="7.56"/>
                    <measurement group_id="B3" value="64.4" spread="8.23"/>
                    <measurement group_id="B4" value="44.5" spread="5.58"/>
                    <measurement group_id="B5" value="55.6" spread="10.81"/>
                    <measurement group_id="B6" value="72.6" spread="5.29"/>
                    <measurement group_id="B7" value="58.7" spread="11.23"/>
                  </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="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="8"/>
                    <measurement group_id="B7" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Between 18 and 65 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="20"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="44"/>
                  </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="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="9"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="17"/>
                    <measurement group_id="B6" value="6"/>
                    <measurement group_id="B7" value="45"/>
                  </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="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="26"/>
                    <measurement group_id="B6" value="8"/>
                    <measurement group_id="B7" value="66"/>
                  </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>The Pharmacokinetic Analysis Set is defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data are considered sufficient and interpretable. The Safety Analysis Set consists of all enrolled subjects who take at least 1 dose of investigational product and have at least 1 post dose safety assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>SSP-004184 (Mild Renal Impairment)</title>
            <description>All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1</description>
          </group>
          <group group_id="O2">
            <title>SSP-004184 (Moderate Renal Impairment)</title>
            <description>All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1</description>
          </group>
          <group group_id="O3">
            <title>SSP-004184 (Severe Renal Impairment)</title>
            <description>All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1</description>
          </group>
          <group group_id="O4">
            <title>SSP-004184 (End Stage Renal Disease)</title>
            <description>All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1</description>
          </group>
          <group group_id="O5">
            <title>SSP-004184 (Matched Healthy Subjects)</title>
            <description>All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1</description>
          </group>
          <group group_id="O6">
            <title>SSP-004184 (Healthy Elderly Subjects)</title>
            <description>All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1</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>The Pharmacokinetic Analysis Set is defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data are considered sufficient and interpretable. The Safety Analysis Set consists of all enrolled subjects who take at least 1 dose of investigational product and have at least 1 post dose safety assessment.</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="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="26"/>
                <count group_id="O6" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="445892.7" spread="156768.3"/>
                    <measurement group_id="O2" value="932688.3" spread="413237.0"/>
                    <measurement group_id="O3" value="1531185.8" spread="836393.5"/>
                    <measurement group_id="O4" value="1261081.6" spread="611849.8"/>
                    <measurement group_id="O5" value="397400.1" spread="126991.1"/>
                    <measurement group_id="O6" value="559880.8" spread="208295.5"/>
                  </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>The Pharmacokinetic Analysis Set is defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data are considered sufficient and interpretable. The Safety Analysis Set consists of all enrolled subjects who take at least 1 dose of investigational product and have at least 1 post dose safety assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>SSP-004184 (Mild Renal Impairment)</title>
            <description>All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1</description>
          </group>
          <group group_id="O2">
            <title>SSP-004184 (Moderate Renal Impairment)</title>
            <description>All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1</description>
          </group>
          <group group_id="O3">
            <title>SSP-004184 (Severe Renal Impairment)</title>
            <description>All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1</description>
          </group>
          <group group_id="O4">
            <title>SSP-004184 (End Stage Renal Disease)</title>
            <description>All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1</description>
          </group>
          <group group_id="O5">
            <title>SSP-004184 (Matched Healthy Subjects)</title>
            <description>All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1</description>
          </group>
          <group group_id="O6">
            <title>SSP-004184 (Healthy Elderly Subjects)</title>
            <description>All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1</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>The Pharmacokinetic Analysis Set is defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data are considered sufficient and interpretable. The Safety Analysis Set consists of all enrolled subjects who take at least 1 dose of investigational product and have 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="8"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="26"/>
                <count group_id="O6" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="157412.5" spread="39231.8"/>
                    <measurement group_id="O2" value="168362.5" spread="43300.5"/>
                    <measurement group_id="O3" value="158250.0" spread="34154.1"/>
                    <measurement group_id="O4" value="146562.5" spread="51181.4"/>
                    <measurement group_id="O5" value="136588.5" spread="40910.5"/>
                    <measurement group_id="O6" value="161525.0" spread="53088.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Impaired Renal Function</title>
          <description>All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1</description>
        </group>
        <group group_id="E2">
          <title>Matched Healthy Subjects</title>
          <description>All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1</description>
        </group>
        <group group_id="E3">
          <title>Healthy Elderly Subjects</title>
          <description>All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</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="14" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abscess oral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Urine colour abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Liver Function Test Abnormal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Fluid overload</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Hypocalcemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="26"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Chromaturia (drug-induced urine coloration)</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </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/NCT01716455
org study id: SPD602-104
nct id: NCT01716455
lead sponsor: 
has dmc: No
Shire is developing SSP-004184 (FBS0701), a novel iron chelator , for the treatment of
      chronic iron overload in patients with transfusion-dependent hereditary and acquired anemias.
      The primary purpose of the study is to assess the pharmacokinetics of SSP-004184 (FBS0701)
      following a single 75mg/kg dose of SSP-004184 (FBS0701) in healthy adults and elderly
      subjects and in adult subjects with mild, moderate, severe, and end stage renal disease
      (ESRD) degrees of impaired renal function. The results of this study will characterize the
      pharmacokinetics, safety, and tolerability of SSP-004184 (FBS0701) in adult subjects with
      various degrees of renal impairment, and these data will be compared to healthy adult and
      elderly subjects.
allocation: 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.
arm group label: SSP-004184 (Mild Renal Impairment)
arm group type: Experimental
description: All subjects will take a single dose of SSP-004184 (75 mg/kg, oral capsule) on Day 1
arm group label: SSP-004184 (Moderate Renal Impairment)
arm group type: Experimental
description: All subjects will take a single dose of SSP-004184 (75 mg/kg, oral capsule) on Day 1
arm group label: SSP-004184 (Severe Renal Impairment)
arm group type: Experimental
description: All subjects will take a single dose of SSP-004184 (75 mg/kg, oral capsule) on Day 1
arm group label: SSP-004184 (End Stage Renal Disease)
arm group type: Experimental
description: All subjects will take a single dose of SSP-004184 (75 mg/kg, oral capsule) on Day 1
arm group label: SSP-004184 (Healthy Elderly Subjects)
arm group type: Experimental
description: All subjects will take a single dose of SSP-004184 (75 mg/kg, oral capsule) on Day 1
arm group label: SSP-004184 (Matched Healthy Subjects)
arm group type: Experimental
description: All subjects will take a single dose of SSP-004184 (75 mg/kg, oral capsule) on Day 1. Healthy subjects matched to renally impaired subjects in arms 1 through 4. (Note: One healthy subject can match more than one renally impaired subject.)
intervention type: Drug
intervention name: SSP-004184
arm group label: SSP-004184 (End Stage Renal Disease)
arm group label: SSP-004184 (Healthy Elderly Subjects)
arm group label: SSP-004184 (Matched Healthy Subjects)
arm group label: SSP-004184 (Mild Renal Impairment)
arm group label: SSP-004184 (Moderate Renal Impairment)
arm group label: SSP-004184 (Severe Renal Impairment)
other name: SPD602, FBS0701
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 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: Renal Insufficiency
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 