<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/NCT03750565</url>
  </required_header>
  <id_info>
    <org_study_id>0176</org_study_id>
    <nct_id>NCT03750565</nct_id>
  </id_info>
  <brief_title>Multiple Dose Ethnobridging PK Study in Healthy Subjects</brief_title>
  <official_title>A Multiple Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TD-1473 in Healthy Adult Japanese Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Theravance Biopharma</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Theravance Biopharma</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A Phase 1, double blind, placebo controlled, 4 cohort, multiple dose study in healthy adult&#xD;
      Japanese and Caucasian subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 27, 2018</start_date>
  <completion_date type="Actual">February 13, 2019</completion_date>
  <primary_completion_date type="Actual">February 13, 2019</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>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under the concentration-time curve (AUC0 t)</measure>
    <time_frame>Day 1 &amp; Day 14</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the concentration-time curve (AUC0 24)</measure>
    <time_frame>Day 1 &amp; Day 14</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the concentration-time curve (AUCtau)</measure>
    <time_frame>Day 1 &amp; Day 14</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum observed concentration (Cmax)</measure>
    <time_frame>Day 1 &amp; Day 14</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum observed concentration at steady state (Cmax_ss)</measure>
    <time_frame>Day 1 &amp; Day 14</time_frame>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Inflammatory Bowel Diseases</condition>
  <condition>IBD</condition>
  <arm_group>
    <arm_group_label>Cohort 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Japanese subjects will receive oral doses of either TD-1473 - Dose A or placebo (15 healthy Japanese subjects randomized 3:1 to 12 active and 3 placebo) once daily (QD) for 14 consecutive days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Japanese subjects will receive oral doses of either TD-1473 - Dose B or placebo (15 healthy Japanese subjects randomized 3:1 to 12 active and 3 placebo) once daily (QD) for 14 consecutive days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Caucasian subjects will receive oral doses of either TD-1473 - Dose B or placebo (15 healthy Caucasian subjects randomized 3:1 to 12 active and 3 placebo) once daily (QD) for 14 consecutive days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Japanese subjects will receive oral doses of either TD-1473 - Dose C or placebo (15 healthy Japanese subjects randomized 3:1 to 12 active and 3 placebo) once daily (QD) for 14 consecutive days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TD-1473 - Dose A</intervention_name>
    <description>oral capsule/tablet, QD</description>
    <arm_group_label>Cohort 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TD-1473 - Dose B</intervention_name>
    <description>oral capsule/tablet, QD</description>
    <arm_group_label>Cohort 2</arm_group_label>
    <arm_group_label>Cohort 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TD-1473 - Dose C</intervention_name>
    <description>oral capsule/tablet, QD</description>
    <arm_group_label>Cohort 4</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>oral capsule/tablet, QD</description>
    <arm_group_label>Cohort 1</arm_group_label>
    <arm_group_label>Cohort 2</arm_group_label>
    <arm_group_label>Cohort 3</arm_group_label>
    <arm_group_label>Cohort 4</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        For All subjects:&#xD;
&#xD;
          -  Male or female between 18 to 55 years old&#xD;
&#xD;
          -  Female subjects must have documentation of a negative serum pregnancy test,&#xD;
&#xD;
          -  Female subjects must be either of non-childbearing potential or if of childbearing&#xD;
             potential use a highly efficient birth control method&#xD;
&#xD;
          -  Male subjects must be vasectomized with documented medical assessment of the surgical&#xD;
             success, or use acceptable contraception&#xD;
&#xD;
          -  All male subjects must agree to refrain from sperm donation during the study and for&#xD;
             at least 7 days after the last dose of study drug.&#xD;
&#xD;
          -  Body Mass Index (BMI) 18 to 32 kg/m2, inclusive, and weighs at least 50 kg and less&#xD;
             than 90 kg&#xD;
&#xD;
          -  Willing and able to give informed consent&#xD;
&#xD;
          -  Additional inclusion criteria apply&#xD;
&#xD;
        For Japanese subjects only:&#xD;
&#xD;
          -  Subject must have been born in Japan, with 2 Japanese biological parents and 4&#xD;
             Japanese grandparents as confirmed by interview.&#xD;
&#xD;
          -  Subject has lived no longer than 10 years outside of Japan.&#xD;
&#xD;
          -  Subject had no significant change in lifestyle, including diet, since leaving Japan.&#xD;
&#xD;
        For Caucasian subjects only:&#xD;
&#xD;
          -  Subject has 2 Caucasian biological parents and 4 Caucasian grandparents as confirmed&#xD;
             by interview.&#xD;
&#xD;
          -  Subject has lived no longer than 10 years outside of Europe and/or North America.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        For all subjects:&#xD;
&#xD;
          -  Subject is a female who is pregnant, lactating, breastfeeding, or planning to become&#xD;
             pregnant during the study or within 7 days after the last dose of study drug.&#xD;
&#xD;
          -  Subject is a male who is planning to father a child during the study or within 7 days&#xD;
             after the last dose of study drug.&#xD;
&#xD;
          -  Is positive for hepatitis A, B or C, and/or HIV&#xD;
&#xD;
          -  Has clinically significant abnormalities in baseline laboratory evaluations&#xD;
&#xD;
          -  Subject has a clinically significant abnormal electrocardiogram (ECG)&#xD;
&#xD;
          -  Participated in another clinical trial of an investigational drug (or medical device)&#xD;
             within 30 days prior to screening or is currently participating in another trial of an&#xD;
             investigational drug (or medical device) Additional exclusion criteria apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Monitor</last_name>
    <role>Study Director</role>
    <affiliation>Theravance Biopharma</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Theravance Biopharma Investigational Site</name>
      <address>
        <city>Cypress</city>
        <state>California</state>
        <zip>90630</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>January 12, 2021</last_update_submitted>
  <last_update_submitted_qc>January 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Healthy Japanese Subjects</keyword>
  <keyword>Healthy Caucasian Subjects</keyword>
  <keyword>Ethnobridging</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Inflammatory Bowel Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.</ipd_description>
  </patient_data>
  <!-- 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/NCT03750565
org study id: 0176
nct id: NCT03750565
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
A Phase 1, double blind, placebo controlled, 4 cohort, multiple dose study in healthy adult
      Japanese and Caucasian subjects.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Area under the concentration-time curve (AUC0 t)
time frame: Day 1 & Day 14
measure: Area under the concentration-time curve (AUC0 24)
time frame: Day 1 & Day 14
measure: Area under the concentration-time curve (AUCtau)
time frame: Day 1 & Day 14
measure: Maximum observed concentration (Cmax)
time frame: Day 1 & Day 14
measure: Maximum observed concentration at steady state (Cmax_ss)
time frame: Day 1 & Day 14
arm group label: Cohort 1
arm group type: Experimental
description: Japanese subjects will receive oral doses of either TD-1473 - Dose A or placebo (15 healthy Japanese subjects randomized 3:1 to 12 active and 3 placebo) once daily (QD) for 14 consecutive days.
arm group label: Cohort 2
arm group type: Experimental
description: Japanese subjects will receive oral doses of either TD-1473 - Dose B or placebo (15 healthy Japanese subjects randomized 3:1 to 12 active and 3 placebo) once daily (QD) for 14 consecutive days.
arm group label: Cohort 3
arm group type: Experimental
description: Caucasian subjects will receive oral doses of either TD-1473 - Dose B or placebo (15 healthy Caucasian subjects randomized 3:1 to 12 active and 3 placebo) once daily (QD) for 14 consecutive days.
arm group label: Cohort 4
arm group type: Experimental
description: Japanese subjects will receive oral doses of either TD-1473 - Dose C or placebo (15 healthy Japanese subjects randomized 3:1 to 12 active and 3 placebo) once daily (QD) for 14 consecutive days.
intervention type: Drug
intervention name: TD-1473 - Dose A
description: oral capsule/tablet, QD
arm group label: Cohort 1
intervention type: Drug
intervention name: TD-1473 - Dose B
description: oral capsule/tablet, QD
arm group label: Cohort 2
arm group label: Cohort 3
intervention type: Drug
intervention name: TD-1473 - Dose C
description: oral capsule/tablet, QD
arm group label: Cohort 4
intervention type: Drug
intervention name: Placebo
description: oral capsule/tablet, QD
arm group label: Cohort 1
arm group label: Cohort 2
arm group label: Cohort 3
arm group label: Cohort 4
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Medical Monitor
role: Study Director
affiliation: Theravance Biopharma
facility: 
country: United States
responsible party type: Sponsor
mesh term: Inflammatory Bowel Diseases
sharing ipd: No
ipd description: Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.