<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/NCT03043248</url>
  </required_header>
  <id_info>
    <org_study_id>700P1C03</org_study_id>
    <nct_id>NCT03043248</nct_id>
  </id_info>
  <brief_title>TRK-700 Drug-Drug Interaction Study With Digoxin and Midazolam</brief_title>
  <official_title>TRK-700 Drug-Drug Interaction Study With Digoxin and Midazolam in Healthy Adults</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study comprises 2 cohorts, and in each cohort, the study will be conducted as an&#xD;
      open-label add-on study.&#xD;
&#xD;
      The purpose of the study is to investigate the pharmacokinetics of each substrate in&#xD;
      concomitant administration of a single dose of the P-glycoprotein substrate digoxin (Cohort&#xD;
      A) or the CYP3A4 substrate midazolam (Cohort B) during repeated administration of TRK-700 in&#xD;
      healthy adult males.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 6, 2017</start_date>
  <completion_date type="Actual">May 21, 2017</completion_date>
  <primary_completion_date type="Actual">May 13, 2017</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>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under the plasma drug concentration - time curve from administration to the last available concentration measurement of Digoxin and Midazolam(AUClast)</measure>
    <time_frame>Cohort A: up to 72 hours, Cohort B: up to 48 hours</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Cohort A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TRK-700 + Digoxin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TRK-700 + Midazolam</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TRK-700</intervention_name>
    <description>repeated oral administration</description>
    <arm_group_label>Cohort A</arm_group_label>
    <arm_group_label>Cohort B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Digoxin</intervention_name>
    <description>single oral administration with/without TRK-700</description>
    <arm_group_label>Cohort A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Midazolam</intervention_name>
    <description>single oral administration with/without TRK-700</description>
    <arm_group_label>Cohort B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Japanese healthy adult males.&#xD;
&#xD;
          -  Subjects with a BMI of at least 18.0 and less than 30.0 at the screening examination&#xD;
             and the examination at admission.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with significant concomitant or historical disease of the metabolism, liver,&#xD;
             kidneys, blood, lungs, heart, digestive organs, urinary organs, or nerves, or&#xD;
             psychiatric diseases, accompanied by clinical symptoms or with other clinically&#xD;
             significant disease, who are unsuitable for participation in this study, in the&#xD;
             opinion of the investigators.&#xD;
&#xD;
          -  Subjects who are found by the investigators to have significant clinical abnormality&#xD;
             at the screening examination, the examination at admission, or the examination at the&#xD;
             day of first administration of Digoxin or Midazolam.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Tokyo</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>February 2, 2017</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>October 24, 2017</last_update_submitted>
  <last_update_submitted_qc>October 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>TRK-700</keyword>
  <keyword>PK</keyword>
  <keyword>Digoxin</keyword>
  <keyword>Midazolam</keyword>
  <keyword>Drug-Drug interaction</keyword>
  <keyword>P-glycoprotein</keyword>
  <keyword>CYP3A4</keyword>
  <keyword>MDR1</keyword>
  <keyword>pharmacokinetics</keyword>
  <keyword>multidrug resistance 1</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Digoxin</mesh_term>
    <mesh_term>Midazolam</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/NCT03043248
org study id: 700P1C03
nct id: NCT03043248
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study comprises 2 cohorts, and in each cohort, the study will be conducted as an
      open-label add-on study.

      The purpose of the study is to investigate the pharmacokinetics of each substrate in
      concomitant administration of a single dose of the P-glycoprotein substrate digoxin (Cohort
      A) or the CYP3A4 substrate midazolam (Cohort B) during repeated administration of TRK-700 in
      healthy adult males.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Area under the plasma drug concentration - time curve from administration to the last available concentration measurement of Digoxin and Midazolam(AUClast)
time frame: Cohort A: up to 72 hours, Cohort B: up to 48 hours
arm group label: Cohort A
arm group type: Experimental
description: TRK-700 + Digoxin
arm group label: Cohort B
arm group type: Experimental
description: TRK-700 + Midazolam
intervention type: Drug
intervention name: TRK-700
description: repeated oral administration
arm group label: Cohort A
arm group label: Cohort B
intervention type: Drug
intervention name: Digoxin
description: single oral administration with/without TRK-700
arm group label: Cohort A
intervention type: Drug
intervention name: Midazolam
description: single oral administration with/without TRK-700
arm group label: Cohort B
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Digoxin
mesh term: Midazolam