<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/NCT02215941</url>
  </required_header>
  <id_info>
    <org_study_id>TV45070-PK-10033</org_study_id>
    <nct_id>NCT02215941</nct_id>
  </id_info>
  <brief_title>Study to Characterize the Pharmacokinetics and Safety of TV-45070 Ointment in Healthy Volunteers</brief_title>
  <official_title>A Randomized, Double Blind, Placebo-Controlled, Parallel Group, Dose Escalation Study to Characterize the Pharmacokinetics and Safety of 8% TV-45070 Ointment Following 7.5 Days of Twice Daily Topical Application in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Teva Branded Pharmaceutical Products R&amp;D, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Teva Branded Pharmaceutical Products R&amp;D, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to characterize the pharmacokinetics of TV-45070 in&#xD;
      plasma following single and multiple-dose topical application of 8% TV-45070 ointment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">November 2014</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>Other</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Plasma concentrations</measure>
    <time_frame>Day 8</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Drug level in skin</measure>
    <time_frame>Days 1, 8, 15, 22, 29</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Excretion of drug in urine</measure>
    <time_frame>Day 8</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Identification of metabolites in blood</measure>
    <time_frame>Days 8, 10</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Identification of metabolites in urine</measure>
    <time_frame>Day 8</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Identification of metabolites in skin</measure>
    <time_frame>Days 1, 8, 15, 22, 29</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraepidermal nerve fiber density in skin</measure>
    <time_frame>Days 1, 8, 15, 29</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Adverse Events</measure>
    <time_frame>10 Weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Pharmacokinetics</condition>
  <arm_group>
    <arm_group_label>TV-45070 7%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>twice daily topical application to 7% body surface area for 7.5 days (15 applications)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TV-45070 21%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>twice daily topical application to 21% body surface area for 7.5 days (15 applications)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TV-45070 53%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>twice daily topical application to 53% body surface area for 7.5 days (15 applications)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TV-45070</intervention_name>
    <description>TV-45070 8% ointment</description>
    <arm_group_label>TV-45070 21%</arm_group_label>
    <arm_group_label>TV-45070 53%</arm_group_label>
    <arm_group_label>TV-45070 7%</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male and/or female subjects aged 18 to 50 years&#xD;
&#xD;
          -  Body Mass Index (BMI) ≥18.0 and ≤32.0 kg/m2.&#xD;
&#xD;
          -  Able and willing to provide written informed consent.&#xD;
&#xD;
          -  Able and willing to comply with all study procedures and restrictions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History or evidence of clinically significant illness or surgery&#xD;
&#xD;
          -  Presence of open wounds, sunburn, tattoo, major scarring, non-intact or damaged in the&#xD;
             proposed application area that would interfere with the application of the study drug&#xD;
             treatments or biopsies.&#xD;
&#xD;
          -  History of significant drug or alcohol abuse&#xD;
&#xD;
          -  Use of prescription drugs within 30 days or 5 half-lives (whichever is longer) prior&#xD;
             to Day 1.&#xD;
&#xD;
          -  Use of topical application of an OTC medicated or prescription medication or other&#xD;
             skin creams/ointments (eg, moisturizers, balms) in the areas intended for study drug&#xD;
             administration within 7 days prior to Day 1. Use of topical capsaicin within 6 months&#xD;
             prior to Day 1.&#xD;
&#xD;
          -  Pregnant or nursing females&#xD;
&#xD;
          -  Shaving or waxing the planned study treatment application area within 7 days prior Day&#xD;
             1.&#xD;
&#xD;
          -  Laser hair removal of the planned study treatment application area within 2 months&#xD;
             prior to Day 1.&#xD;
&#xD;
               -  other criteria apply, please contact the investigator for more information&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Teva Medical Expert, MD</last_name>
    <role>Study Director</role>
    <affiliation>Teva Branded Pharmaceutical Products R&amp;D, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Teva Investigational Site 12961</name>
      <address>
        <city>Lenexa</city>
        <state>Kansas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>August 6, 2014</study_first_submitted>
  <study_first_submitted_qc>August 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>November 5, 2021</last_update_submitted>
  <last_update_submitted_qc>November 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02215941
org study id: TV45070-PK-10033
nct id: NCT02215941
lead sponsor: 
has dmc: No
The primary objective of this study is to characterize the pharmacokinetics of TV-45070 in
      plasma following single and multiple-dose topical application of 8% TV-45070 ointment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Triple (Participant, Care Provider, Investigator)
measure: Plasma concentrations
time frame: Day 8
measure: Drug level in skin
time frame: Days 1, 8, 15, 22, 29
measure: Excretion of drug in urine
time frame: Day 8
measure: Identification of metabolites in blood
time frame: Days 8, 10
measure: Identification of metabolites in urine
time frame: Day 8
measure: Identification of metabolites in skin
time frame: Days 1, 8, 15, 22, 29
measure: Intraepidermal nerve fiber density in skin
time frame: Days 1, 8, 15, 29
measure: Percentage of Participants with Adverse Events
time frame: 10 Weeks
arm group label: TV-45070 7%
arm group type: Experimental
description: twice daily topical application to 7% body surface area for 7.5 days (15 applications)
arm group label: TV-45070 21%
arm group type: Experimental
description: twice daily topical application to 21% body surface area for 7.5 days (15 applications)
arm group label: TV-45070 53%
arm group type: Experimental
description: twice daily topical application to 53% body surface area for 7.5 days (15 applications)
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: TV-45070
description: TV-45070 8% ointment
arm group label: TV-45070 21%
arm group label: TV-45070 53%
arm group label: TV-45070 7%
intervention type: Drug
intervention name: Placebo
description: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Teva Medical Expert, MD
role: Study Director
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
facility: 
country: United States
responsible party type: Sponsor