<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/NCT03279146</url>
  </required_header>
  <id_info>
    <org_study_id>CTRV-TXL-103</org_study_id>
    <nct_id>NCT03279146</nct_id>
  </id_info>
  <brief_title>A Single Dose Study Evaluating PK of TXL Oral Formulations in Healthy Subjects</brief_title>
  <official_title>Open-Label, Part-Randomized Study Designed to Evaluate the PK Profile of Tenofovir Exalidex (TXL) Following Single Dose of Oral Formulations in Comparison to a Reference IR TXL Tablet in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ContraVir Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ContraVir</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase 1 study to evaluate the PK profile of TXL oral formulations in healthy&#xD;
      subjects&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase 1 study to evaluate the PK profile of different oral formulations of TXL&#xD;
      following single dose administration in healthy subjects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 6, 2017</start_date>
  <completion_date type="Actual">June 16, 2018</completion_date>
  <primary_completion_date type="Actual">June 9, 2018</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>Crossover Assignment</intervention_model>
    <intervention_model_description>Drug: Tenofovir Exalidex (TXL) oral formulations Other names: Lipid conjugateTFV</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of pharmacokinetics of single dose oral formulations of TXL in fasted state</measure>
    <time_frame>up to four days post dose</time_frame>
    <description>Measuring Cmax, the peak plasma concentration</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Regimen A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Immediate release tablet Tenofovir exalidex (TXL)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Regimen B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>New Formulation 1 Tenofovir exalidex (TXL)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Regimen C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>New formulation 2 Tenofovir exalidex (TXL)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tenofovir exalidex (TXL)</intervention_name>
    <description>Oral formulations</description>
    <arm_group_label>Regimen A</arm_group_label>
    <arm_group_label>Regimen B</arm_group_label>
    <arm_group_label>Regimen C</arm_group_label>
    <other_name>Lipid conjugate YTFV</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age:18-55 Capable of giving written informed consent Capable of completing study&#xD;
             requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History or medical condition which could impact patient safety History of drug or&#xD;
             alcohol abuse within past 2 years Positive result for HIV, HBV, or HCV Participation&#xD;
             in another clinical trial within the past 90 days&#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>John Sullivan-Bolyai, MD, MPH</last_name>
    <role>Study Chair</role>
    <affiliation>ContraVir Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Quotient Clinical</name>
      <address>
        <city>Nottingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>August 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>July 31, 2018</last_update_submitted>
  <last_update_submitted_qc>July 31, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tenofovir</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03279146
org study id: CTRV-TXL-103
nct id: NCT03279146
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This is a Phase 1 study to evaluate the PK profile of TXL oral formulations in healthy
      subjects
This is a Phase 1 study to evaluate the PK profile of different oral formulations of TXL
      following single dose administration in healthy subjects.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Drug: Tenofovir Exalidex (TXL) oral formulations Other names: Lipid conjugateTFV
primary purpose: Other
masking: None (Open Label)
measure: Evaluation of pharmacokinetics of single dose oral formulations of TXL in fasted state
time frame: up to four days post dose
description: Measuring Cmax, the peak plasma concentration
arm group label: Regimen A
arm group type: Active Comparator
description: Immediate release tablet Tenofovir exalidex (TXL)
arm group label: Regimen B
arm group type: Experimental
description: New Formulation 1 Tenofovir exalidex (TXL)
arm group label: Regimen C
arm group type: Experimental
description: New formulation 2 Tenofovir exalidex (TXL)
intervention type: Drug
intervention name: Tenofovir exalidex (TXL)
description: Oral formulations
arm group label: Regimen A
arm group label: Regimen B
arm group label: Regimen C
other name: Lipid conjugate YTFV
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: John Sullivan-Bolyai, MD, MPH
role: Study Chair
affiliation: ContraVir Pharmaceuticals
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Tenofovir
sharing ipd: Undecided