<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/NCT03002233</url>
  </required_header>
  <id_info>
    <org_study_id>EU820UPC01</org_study_id>
    <nct_id>NCT03002233</nct_id>
  </id_info>
  <brief_title>TRK-820 Study in Subjects on Hemodialysis With or Without Uremic Pruritus</brief_title>
  <official_title>A Phase 1 Study to Observe Safety and Tolerability of Single and Multiple Doses of TRK-820 in Subjects on Hemodialysis and to Observe the Effect on Uremic Pruritus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Toray Industries, Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Toray Industries, Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a 2-part study.&#xD;
&#xD;
      Part A is a single-dose, open-label study design to determine the PK, safety and tolerability&#xD;
      of 5 μg TRK-820 oral administration in subjects with end-stage renal disease (ESRD) who&#xD;
      require hemodialysis.&#xD;
&#xD;
      Part B is a multiple dose, open-label study design to determine the PK, PD, safety and&#xD;
      tolerability of multiple doses in subjects with ESRD who require hemodialysis with refractory&#xD;
      uremic pruritus (UP). Each subject will receive 3 doses of TRK-820 (2.5, 5 and 10 μg).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">July 2017</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetic parameters: area under the time curve from time zero to 24 hours postdose(AUC0-24h)</measure>
    <time_frame>Part A; predose to 24 hours postdose, Part B; predose to 24 hours postdose each dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic parameters: area under the time curve from time zero to the last quantifiable concentration(AUC0-last)</measure>
    <time_frame>Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic parameters: area under the time curve from time zero extrapolated to infinity(AUC0-inf)</measure>
    <time_frame>Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic parameters: maximum observed plasma concentration (Cmax)</measure>
    <time_frame>Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic parameters: time to maximum plasma concentration(Tmax)</measure>
    <time_frame>Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic parameters: apparent elimination half-life in plasma(t½)</measure>
    <time_frame>Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic parameters: plasma concentration at 24 hours postdose(C24h)</measure>
    <time_frame>Part A; 24 hours postdose, Part B; 24 hours postdose each dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic parameters: apparent total clearance(CL/F)</measure>
    <time_frame>Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic parameters: terminal elimination rate(λz)</measure>
    <time_frame>Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic parameters: apparent distribution volume(Vz/F)</measure>
    <time_frame>Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic parameters: mean residence time(MRT)</measure>
    <time_frame>Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacodynamic parameters: Visual Analogue Scale (VAS) reduction from baseline</measure>
    <time_frame>Part B only; Baseline to week 5</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Uremic Pruritus</condition>
  <arm_group>
    <arm_group_label>TRK-820</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PartA: 5 μg PartB: 2.5-10 μg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TRK-820</intervention_name>
    <arm_group_label>TRK-820</arm_group_label>
    <other_name>Nalfurafine Hydrochloride</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult non-smoking male and female subjects (≥ 18 years of age) who have ESRD requiring&#xD;
             hemodialysis, at least 3 times a week.&#xD;
&#xD;
          -  Subjects has a clinical diagnosis of UP, which is uncontrolled by current medications&#xD;
             or treatments.(Part B only)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has a known hypersensitivity to opioids or the ingredients of the study&#xD;
             medication.&#xD;
&#xD;
          -  Subject has pruritus other than related to ESRD (i.e., UP).(Part B only)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Bulgaria</name>
      <address>
        <city>Bulgaria</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Germany</name>
      <address>
        <city>Germany</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bulgaria</country>
    <country>Germany</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <last_update_submitted>July 19, 2017</last_update_submitted>
  <last_update_submitted_qc>July 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>TRK-820</keyword>
  <keyword>Hemodialysis</keyword>
  <keyword>Uremic Pruritus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pruritus</mesh_term>
  </condition_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/NCT03002233
org study id: EU820UPC01
nct id: NCT03002233
lead sponsor: 
has dmc: No
This study is a 2-part study.

      Part A is a single-dose, open-label study design to determine the PK, safety and tolerability
      of 5 μg TRK-820 oral administration in subjects with end-stage renal disease (ESRD) who
      require hemodialysis.

      Part B is a multiple dose, open-label study design to determine the PK, PD, safety and
      tolerability of multiple doses in subjects with ESRD who require hemodialysis with refractory
      uremic pruritus (UP). Each subject will receive 3 doses of TRK-820 (2.5, 5 and 10 μg).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pharmacokinetic parameters: area under the time curve from time zero to 24 hours postdose(AUC0-24h)
time frame: Part A; predose to 24 hours postdose, Part B; predose to 24 hours postdose each dose
measure: Pharmacokinetic parameters: area under the time curve from time zero to the last quantifiable concentration(AUC0-last)
time frame: Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
measure: Pharmacokinetic parameters: area under the time curve from time zero extrapolated to infinity(AUC0-inf)
time frame: Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
measure: Pharmacokinetic parameters: maximum observed plasma concentration (Cmax)
time frame: Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
measure: Pharmacokinetic parameters: time to maximum plasma concentration(Tmax)
time frame: Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
measure: Pharmacokinetic parameters: apparent elimination half-life in plasma(t½)
time frame: Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
measure: Pharmacokinetic parameters: plasma concentration at 24 hours postdose(C24h)
time frame: Part A; 24 hours postdose, Part B; 24 hours postdose each dose
measure: Pharmacokinetic parameters: apparent total clearance(CL/F)
time frame: Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
measure: Pharmacokinetic parameters: terminal elimination rate(λz)
time frame: Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
measure: Pharmacokinetic parameters: apparent distribution volume(Vz/F)
time frame: Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
measure: Pharmacokinetic parameters: mean residence time(MRT)
time frame: Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
measure: Pharmacodynamic parameters: Visual Analogue Scale (VAS) reduction from baseline
time frame: Part B only; Baseline to week 5
arm group label: TRK-820
arm group type: Experimental
description: PartA: 5 μg PartB: 2.5-10 μg
intervention type: Drug
intervention name: TRK-820
arm group label: TRK-820
other name: Nalfurafine Hydrochloride
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: Bulgaria
country: Germany
responsible party type: Sponsor
mesh term: Pruritus