<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/NCT03755778</url>
  </required_header>
  <id_info>
    <org_study_id>EDP 938-003</org_study_id>
    <nct_id>NCT03755778</nct_id>
  </id_info>
  <brief_title>Drug-Drug Interaction Study Between EDP-938, Itraconazole, Rifampin, and Quinidine in Healthy Subjects</brief_title>
  <official_title>A Non-Randomized, Open-Label, Three-Part, Drug-Drug Interaction Study to Evaluate the Effects of Itraconazole, Rifampin, and Quinidine on the Pharmacokinetics and Safety of EDP-938 in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Enanta Pharmaceuticals, Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pharmaceutical Research Associates</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Enanta Pharmaceuticals, Inc</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 Non-Randomized, Open-Label, Three-Part, Drug-Drug Interaction Study to Evaluate the Effects&#xD;
      of Itraconazole, Rifampin, and Quinidine on the Pharmacokinetics and Safety of EDP-938 in&#xD;
      Healthy Subjects&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 29, 2018</start_date>
  <completion_date type="Actual">January 27, 2019</completion_date>
  <primary_completion_date type="Actual">January 21, 2019</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>
    <intervention_model_description>3-Part Single Group study</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cmax of EDP-938 with and without coadministration with itraconazole</measure>
    <time_frame>Up to 19 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC of EDP-938 with and without coadministration with itraconazole</measure>
    <time_frame>Up to 19 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax of EDP-938 with and without coadministration with rifampin</measure>
    <time_frame>Up to 17 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC of EDP-938 with and without coadministration with rifampin</measure>
    <time_frame>Up to 17 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax of EDP-938 with and without coadministration with quinidine</measure>
    <time_frame>Up to 13 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC of EDP-938 with and without coadministration with quinidine</measure>
    <time_frame>Up to 13 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety measured by adverse events</measure>
    <time_frame>Up to 25 days</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>RSV Infection</condition>
  <arm_group>
    <arm_group_label>EDP-938 and itraconazole interaction (Part 1)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>EDP-938 and rifampin interaction (Part 2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>EDP-938 and quinidine interaction (Part 3)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>EDP-938</intervention_name>
    <description>Subjects will receive EDP-938 once daily on Day 1 and 14 (Part 1)</description>
    <arm_group_label>EDP-938 and itraconazole interaction (Part 1)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>EDP-938</intervention_name>
    <description>Subjects will receive EDP-938 once daily on Day 1 and 14 (Part 2)</description>
    <arm_group_label>EDP-938 and rifampin interaction (Part 2)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>EDP-938</intervention_name>
    <description>Subjects will receive EDP-938 once daily on Day 1 and 8 (Part 3)</description>
    <arm_group_label>EDP-938 and quinidine interaction (Part 3)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Itraconazole</intervention_name>
    <description>Subjects will receive itraconazole once daily from Day 5 to Day 18</description>
    <arm_group_label>EDP-938 and itraconazole interaction (Part 1)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rifampin</intervention_name>
    <description>Subjects will receive rifampin once daily from Day 5 to Day 16</description>
    <arm_group_label>EDP-938 and rifampin interaction (Part 2)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Quinidine</intervention_name>
    <description>Subjects will receive quinidine once daily from Day 5 to Day 12</description>
    <arm_group_label>EDP-938 and quinidine interaction (Part 3)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  An informed consent document signed and dated by the subject.&#xD;
&#xD;
          -  Healthy male and female subjects of any ethnic origin between the ages of 18 and 55&#xD;
             years, inclusive.&#xD;
&#xD;
          -  Screening body mass index (BMI) of 18 to 30 kg/m2 with a minimum body weight of 50 kg&#xD;
&#xD;
          -  Female subjects of childbearing potential must agree to use two effective methods of&#xD;
             contraception from the date of Screening until 90 days after the last dose of EDP 938.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinically relevant evidence or history of illness or disease.&#xD;
&#xD;
          -  For Part 3 subjects, the following cardiovascular abnormalities:&#xD;
&#xD;
               -  QRS duration &gt;110 ms&#xD;
&#xD;
               -  Incomplete right bundle branch block or any complete bundle branch block&#xD;
&#xD;
               -  Heart rate &lt;40 or &gt;90 beats per minute (per vital sign capture while rested)&#xD;
&#xD;
               -  History of unexplained syncope, structural heart disease, or clinically&#xD;
                  significant arrhythmias&#xD;
&#xD;
               -  Personal or family history of long QT syndrome (genetically proven or suggested&#xD;
                  by sudden death of a close relative due to cardiac causes at a young age) or&#xD;
                  Brugada syndrome&#xD;
&#xD;
               -  PR interval &gt;220 ms or any 2nd or 3rd degree AV block&#xD;
&#xD;
               -  Ventricular pre-excitation&#xD;
&#xD;
          -  Pregnant or nursing females.&#xD;
&#xD;
          -  History of febrile illness within 7 days prior to the first dose of study drug or&#xD;
             subjects with evidence of active infection.&#xD;
&#xD;
          -  A positive urine drug screen at Screening or Day -1.&#xD;
&#xD;
          -  Current tobacco smokers or use of tobacco within 3 months prior to Screening.&#xD;
&#xD;
          -  Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy).&#xD;
&#xD;
          -  History of regular alcohol consumption.&#xD;
&#xD;
          -  Participation in a clinical trial within 30 days prior to the first dose of study&#xD;
             drug.&#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>Enanta Pharmaceuticals</last_name>
    <role>Study Director</role>
    <affiliation>Enanta Pharmaceuticals, Inc</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pharmaceutical Research Associates, Inc.,</name>
      <address>
        <city>Lenexa</city>
        <state>Kansas</state>
        <zip>66219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>June 12, 2019</last_update_submitted>
  <last_update_submitted_qc>June 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>drug-drug interaction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Syncytial Virus Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Itraconazole</mesh_term>
    <mesh_term>Rifampin</mesh_term>
    <mesh_term>Quinidine</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/NCT03755778
org study id: EDP 938-003
nct id: NCT03755778
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
A Non-Randomized, Open-Label, Three-Part, Drug-Drug Interaction Study to Evaluate the Effects
      of Itraconazole, Rifampin, and Quinidine on the Pharmacokinetics and Safety of EDP-938 in
      Healthy Subjects
allocation: Non-Randomized
intervention model: Single Group Assignment
intervention model description: 3-Part Single Group study
primary purpose: Basic Science
masking: None (Open Label)
measure: Cmax of EDP-938 with and without coadministration with itraconazole
time frame: Up to 19 days
measure: AUC of EDP-938 with and without coadministration with itraconazole
time frame: Up to 19 days
measure: Cmax of EDP-938 with and without coadministration with rifampin
time frame: Up to 17 days
measure: AUC of EDP-938 with and without coadministration with rifampin
time frame: Up to 17 days
measure: Cmax of EDP-938 with and without coadministration with quinidine
time frame: Up to 13 days
measure: AUC of EDP-938 with and without coadministration with quinidine
time frame: Up to 13 days
measure: Safety measured by adverse events
time frame: Up to 25 days
arm group label: EDP-938 and itraconazole interaction (Part 1)
arm group type: Experimental
arm group label: EDP-938 and rifampin interaction (Part 2)
arm group type: Experimental
arm group label: EDP-938 and quinidine interaction (Part 3)
arm group type: Experimental
intervention type: Drug
intervention name: EDP-938
description: Subjects will receive EDP-938 once daily on Day 1 and 14 (Part 1)
arm group label: EDP-938 and itraconazole interaction (Part 1)
intervention type: Drug
intervention name: EDP-938
description: Subjects will receive EDP-938 once daily on Day 1 and 14 (Part 2)
arm group label: EDP-938 and rifampin interaction (Part 2)
intervention type: Drug
intervention name: EDP-938
description: Subjects will receive EDP-938 once daily on Day 1 and 8 (Part 3)
arm group label: EDP-938 and quinidine interaction (Part 3)
intervention type: Drug
intervention name: Itraconazole
description: Subjects will receive itraconazole once daily from Day 5 to Day 18
arm group label: EDP-938 and itraconazole interaction (Part 1)
intervention type: Drug
intervention name: Rifampin
description: Subjects will receive rifampin once daily from Day 5 to Day 16
arm group label: EDP-938 and rifampin interaction (Part 2)
intervention type: Drug
intervention name: Quinidine
description: Subjects will receive quinidine once daily from Day 5 to Day 12
arm group label: EDP-938 and quinidine interaction (Part 3)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Enanta Pharmaceuticals
role: Study Director
affiliation: Enanta Pharmaceuticals, Inc
facility: 
country: United States
responsible party type: Sponsor
mesh term: Respiratory Syncytial Virus Infections
mesh term: Itraconazole
mesh term: Rifampin
mesh term: Quinidine