<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/NCT03284164</url>
  </required_header>
  <id_info>
    <org_study_id>CTRV-TXL-104</org_study_id>
    <nct_id>NCT03284164</nct_id>
  </id_info>
  <brief_title>Evaluation of Effect of Renal Impairment on the PK of Tenofovir Exalidex</brief_title>
  <official_title>An Open-Label Study to Investigate the Effect of Renal Impairment on the Pharmacokinectics of Tenofovir Exalidex</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase 1 study to investigate the effects of Renal Impairment on the&#xD;
      pharmacokinetics of Tenofovir exalidex&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase 1 study to investigate the effects of Renal Impairment (mild, moderate and&#xD;
      severe) on the pharmacokinetics of Tenofovir Exalidex&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 28, 2017</start_date>
  <completion_date type="Actual">February 20, 2018</completion_date>
  <primary_completion_date type="Actual">January 17, 2018</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Tenofovir exalidex (TXL)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of the pharmacokinetics of TXL in subjects with RI compared to matching healthy volunteers</measure>
    <time_frame>up to six days post dose</time_frame>
    <description>Measuring Cmax : the peak plasma concentration</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the adverse events for TXL in RI subjects</measure>
    <time_frame>up to six days post dose</time_frame>
    <description>review of Adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of safety labs for TXL in RI subjects</measure>
    <time_frame>up to six days post dose</time_frame>
    <description>review of safety labs</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Renal Impairment</condition>
  <arm_group>
    <arm_group_label>Healthy Subjects</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy Subjects matched to RI subjects Tenofovir Exalidex (TXL)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Severe RI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Severe Renal Impairment subjects Tenofovir Exalidex (TXL)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tenofovir Exalidex (TXL)</intervention_name>
    <description>Drug: Tenofovir Exalidex (TXL)</description>
    <arm_group_label>Healthy Subjects</arm_group_label>
    <arm_group_label>Severe RI</arm_group_label>
    <other_name>lipid conjugate TFV</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 18 years of age and over&#xD;
&#xD;
          -  Capable of giving written informed consent&#xD;
&#xD;
          -  Capable of completing study requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Positive result for HIV, HBV, or HCV&#xD;
&#xD;
          -  History or medical condition which could impact patient safety&#xD;
&#xD;
          -  Current or past abuse of alcohol or drugs&#xD;
&#xD;
          -  Participation in another clinical trial within the past 30 days&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</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>Orlando Clinical Research Center</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32809</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>September 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>June 5, 2018</last_update_submitted>
  <last_update_submitted_qc>June 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Renal Insufficiency</mesh_term>
  </condition_browse>
  <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/NCT03284164
org study id: CTRV-TXL-104
nct id: NCT03284164
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a Phase 1 study to investigate the effects of Renal Impairment on the
      pharmacokinetics of Tenofovir exalidex
This is a Phase 1 study to investigate the effects of Renal Impairment (mild, moderate and
      severe) on the pharmacokinetics of Tenofovir Exalidex
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Tenofovir exalidex (TXL)
primary purpose: Treatment
masking: None (Open Label)
measure: Evaluation of the pharmacokinetics of TXL in subjects with RI compared to matching healthy volunteers
time frame: up to six days post dose
description: Measuring Cmax : the peak plasma concentration
measure: Evaluation of the adverse events for TXL in RI subjects
time frame: up to six days post dose
description: review of Adverse events
measure: Evaluation of safety labs for TXL in RI subjects
time frame: up to six days post dose
description: review of safety labs
arm group label: Healthy Subjects
arm group type: Experimental
description: Healthy Subjects matched to RI subjects Tenofovir Exalidex (TXL)
arm group label: Severe RI
arm group type: Experimental
description: Severe Renal Impairment subjects Tenofovir Exalidex (TXL)
intervention type: Drug
intervention name: Tenofovir Exalidex (TXL)
description: Drug: Tenofovir Exalidex (TXL)
arm group label: Healthy Subjects
arm group label: Severe RI
other name: lipid conjugate TFV
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: John Sullivan-Bolyai, MD, MPH
role: Study Chair
affiliation: ContraVir Pharmaceuticals
facility: 
country: United States
responsible party type: Sponsor
mesh term: Renal Insufficiency
mesh term: Tenofovir
sharing ipd: Undecided