<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/NCT03306667</url>
  </required_header>
  <id_info>
    <org_study_id>FYU-981-015</org_study_id>
    <nct_id>NCT03306667</nct_id>
  </id_info>
  <brief_title>Clinical Pharmacology of FYU-981 (Subjects With Hepatic Insufficiency)</brief_title>
  <official_title>Clinical Pharmacology Study of FYU-981 for Subjects With Hepatic Insufficiency</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mochida Pharmaceutical Company, Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fuji Yakuhin Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Mochida Pharmaceutical Company, Ltd.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the pharmacokinetics, pharmacodynamics and safety&#xD;
      after single oral administration of FYU-981 to subjects with hepatic insufficiency and with&#xD;
      normal hepatic function.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 6, 2017</start_date>
  <completion_date type="Actual">June 25, 2018</completion_date>
  <primary_completion_date type="Actual">June 20, 2018</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetics (Cmax: Maximum plasma concentration)</measure>
    <time_frame>48 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)</measure>
    <time_frame>48 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics (T1/2: Elimination half-life of plasma concentration)</measure>
    <time_frame>48 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics (AUC: Area under the plasma concentration-time curve)</measure>
    <time_frame>48 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed)</measure>
    <time_frame>48 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics (kel: Elimination rate constant)</measure>
    <time_frame>48 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed)</measure>
    <time_frame>48 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics (MRT: Mean residence time)</measure>
    <time_frame>48 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacodynamics (Serum concentration of uric acid)</measure>
    <time_frame>48 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacodynamics (Amount of uric acid excreted in urine)</measure>
    <time_frame>48 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety (Incidence of treatment-emergent adverse events)</measure>
    <time_frame>192 hours</time_frame>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Hepatic Insufficiency</condition>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Normal group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy control subjects</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mild hepatic-insufficient group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with mild hepatic impaired function (Child-Pugh A)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Moderate hepatic-insufficient group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with moderate hepatic impaired function (Child-Pugh B)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Severe hepatic-insufficient group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with severe hepatic impaired function (Child-Pugh C)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FYU-981</intervention_name>
    <description>Oral single dosing</description>
    <arm_group_label>Mild hepatic-insufficient group</arm_group_label>
    <arm_group_label>Moderate hepatic-insufficient group</arm_group_label>
    <arm_group_label>Normal group</arm_group_label>
    <arm_group_label>Severe hepatic-insufficient group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult healthy subjects or adult cirrhosis patients&#xD;
&#xD;
          -  Body mass index: &gt;=18.5 and &lt;30.0&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with any disease or any history of diseases that might be unsuitable for&#xD;
             participation in the clinical study (except for cirrhosis patients with hepatic&#xD;
             diseases)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shigeki Matsumoto</last_name>
    <role>Study Director</role>
    <affiliation>Clinical Research Department</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mochida Investigational sites</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>September 20, 2017</study_first_submitted>
  <study_first_submitted_qc>October 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>September 21, 2018</last_update_submitted>
  <last_update_submitted_qc>September 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 24, 2018</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>Hepatic Insufficiency</mesh_term>
    <mesh_term>Liver Failure</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dotinurad</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03306667
org study id: FYU-981-015
nct id: NCT03306667
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to assess the pharmacokinetics, pharmacodynamics and safety
      after single oral administration of FYU-981 to subjects with hepatic insufficiency and with
      normal hepatic function.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Pharmacokinetics (Cmax: Maximum plasma concentration)
time frame: 48 hours
measure: Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)
time frame: 48 hours
measure: Pharmacokinetics (T1/2: Elimination half-life of plasma concentration)
time frame: 48 hours
measure: Pharmacokinetics (AUC: Area under the plasma concentration-time curve)
time frame: 48 hours
measure: Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed)
time frame: 48 hours
measure: Pharmacokinetics (kel: Elimination rate constant)
time frame: 48 hours
measure: Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed)
time frame: 48 hours
measure: Pharmacokinetics (MRT: Mean residence time)
time frame: 48 hours
measure: Pharmacodynamics (Serum concentration of uric acid)
time frame: 48 hours
measure: Pharmacodynamics (Amount of uric acid excreted in urine)
time frame: 48 hours
measure: Safety (Incidence of treatment-emergent adverse events)
time frame: 192 hours
arm group label: Normal group
arm group type: Experimental
description: Healthy control subjects
arm group label: Mild hepatic-insufficient group
arm group type: Experimental
description: Patients with mild hepatic impaired function (Child-Pugh A)
arm group label: Moderate hepatic-insufficient group
arm group type: Experimental
description: Patients with moderate hepatic impaired function (Child-Pugh B)
arm group label: Severe hepatic-insufficient group
arm group type: Experimental
description: Patients with severe hepatic impaired function (Child-Pugh C)
intervention type: Drug
intervention name: FYU-981
description: Oral single dosing
arm group label: Mild hepatic-insufficient group
arm group label: Moderate hepatic-insufficient group
arm group label: Normal group
arm group label: Severe hepatic-insufficient group
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Shigeki Matsumoto
role: Study Director
affiliation: Clinical Research Department
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Hepatic Insufficiency
mesh term: Liver Failure
mesh term: Dotinurad