<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/NCT03783897</url>
  </required_header>
  <id_info>
    <org_study_id>EDP 305-008</org_study_id>
    <nct_id>NCT03783897</nct_id>
  </id_info>
  <brief_title>A Drug-drug Interaction Study to Investigate the Effect of Coadministration of EDP-305 on the PK of a Combined Oral Contraceptive in Healthy Female Subjects</brief_title>
  <official_title>A Phase 1, Open-label, Fixed-sequence Study to Investigate the Effects of EDP 305 on the Pharmacokinetics of a Combined Oral Contraceptive in Healthy Adult Female Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Enanta Pharmaceuticals, Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Covance</agency>
      <agency_class>Industry</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 Phase 1, Open-label, Fixed-sequence Study to Investigate the Effects of EDP 305 on the&#xD;
      Pharmacokinetics of a Combined Oral Contraceptive in Healthy Adult Female Subjects&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 27, 2018</start_date>
  <completion_date type="Actual">June 18, 2019</completion_date>
  <primary_completion_date type="Actual">June 4, 2019</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under the plasma concentration-time (AUC0-τ) curve for OC with and without coadministration with EDP-305</measure>
    <time_frame>Day 21 (cycle 2 and cycle 3)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax for OC with and without coadministration with EDP-305</measure>
    <time_frame>Day 21 (cycle 2 and cycle 3)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration-time (AUC0-τ) curve for EDP-305 when coadministration with OC</measure>
    <time_frame>Days 14, 20-22 (cycle 3)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax for EDP-305 when coadministration with OC</measure>
    <time_frame>Days 14, 20-22 (cycle 3)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety measured by adverse events</measure>
    <time_frame>Approximately 91 days</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">43</enrollment>
  <condition>NASH - Nonalcoholic Steatohepatitis</condition>
  <arm_group>
    <arm_group_label>EDP-305 and Oral Contraceptive</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>EDP-305</intervention_name>
    <description>Subjects will receive EDP-305 on on Days 11 through 21 of cycle 3</description>
    <arm_group_label>EDP-305 and Oral Contraceptive</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oral Contraceptive</intervention_name>
    <description>Subjects will receive active Oral Contraceptive on Days 1-21 and inert OC on Days 22-28 of cycles 1, 2 and 3</description>
    <arm_group_label>EDP-305 and Oral Contraceptive</arm_group_label>
    <other_name>ethinyl estradiol [EE] and norgestimate [NGM])</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Females of childbearing potential, 18 to 45 years of age, inclusive.&#xD;
             Follicle-stimulating hormone levels may be used to confirm premenopausal status,&#xD;
             including females who have had a hysterectomy with ovaries still intact. Women who&#xD;
             otherwise meet inclusion criteria and who have had tubal ligation, tubal occlusion, or&#xD;
             bilateral salpingectomy will be allowed.&#xD;
&#xD;
          -  Body mass index between 18.0 and 32.0 kg/m2, inclusive.&#xD;
&#xD;
          -  In good health, determined by no clinically significant findings from medical history,&#xD;
             physical examination, 12 lead ECG, vital signs measurements, and clinical laboratory&#xD;
             evaluations at Screening and Day -1 of the Lead-in Period&#xD;
&#xD;
          -  Must not be pregnant or lactating, and must agree to use contraception&#xD;
&#xD;
          -  Subjects must have documentation of normal results of up-to-date cervical cancer&#xD;
             screening as specified in the American College of Obstetricians and Gynecologists&#xD;
             guidelines:&#xD;
&#xD;
               1. Women aged &lt; 21 years: no documentation required&#xD;
&#xD;
               2. Women aged 21 to 29: normal Pap smear test result within previous 3 years&#xD;
&#xD;
               3. Women aged 30 to 45: normal Pap smear test result and negative high-risk human&#xD;
                  papilloma virus test within previous 5 years, OR normal Pap smear test result&#xD;
                  within previous 3 years If documented results are not available at Screening, the&#xD;
                  subject must provide documentation of normal results prior to Day -1 of the&#xD;
                  Lead-in Period.&#xD;
&#xD;
          -  Able to comprehend and willing to sign an ICF.&#xD;
&#xD;
          -  Willing and able to adhere to assessments, prohibitions, and restrictions as described&#xD;
             in this protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant history or clinical manifestation of any metabolic, allergic,&#xD;
             dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, GI,&#xD;
             neurological, respiratory, endocrine, or psychiatric disorder, as determined by the&#xD;
             Investigator (or designee).&#xD;
&#xD;
          -  Are pregnant, breastfeeding, or are planning to conceive during the study.&#xD;
&#xD;
          -  Have been administered injectable contraceptives within 12 months prior to Day -1 of&#xD;
             the Lead in Period, or had exposure to a hormonal intrauterine device or topical&#xD;
             controlled delivery contraceptives (patch) within 3 months prior to Day -1 of the&#xD;
             Lead-in Period.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Enanta Pharmaceuticals, Inc</last_name>
    <role>Study Director</role>
    <affiliation>Enanta Pharmaceuticals, Inc</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Covance Clinical Research Unit</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 21, 2018</study_first_posted>
  <last_update_submitted>July 23, 2019</last_update_submitted>
  <last_update_submitted_qc>July 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>OC DDI, drug-drug interaction, oral contraceptive</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fatty Liver</mesh_term>
    <mesh_term>Non-alcoholic Fatty Liver Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ethinyl Estradiol</mesh_term>
    <mesh_term>Norgestimate</mesh_term>
    <mesh_term>Contraceptive Agents</mesh_term>
    <mesh_term>Contraceptives, Oral</mesh_term>
    <mesh_term>Estradiol</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/NCT03783897
org study id: EDP 305-008
nct id: NCT03783897
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
A Phase 1, Open-label, Fixed-sequence Study to Investigate the Effects of EDP 305 on the
      Pharmacokinetics of a Combined Oral Contraceptive in Healthy Adult Female Subjects
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Area under the plasma concentration-time (AUC0-τ) curve for OC with and without coadministration with EDP-305
time frame: Day 21 (cycle 2 and cycle 3)
measure: Cmax for OC with and without coadministration with EDP-305
time frame: Day 21 (cycle 2 and cycle 3)
measure: Area under the plasma concentration-time (AUC0-τ) curve for EDP-305 when coadministration with OC
time frame: Days 14, 20-22 (cycle 3)
measure: Cmax for EDP-305 when coadministration with OC
time frame: Days 14, 20-22 (cycle 3)
measure: Safety measured by adverse events
time frame: Approximately 91 days
arm group label: EDP-305 and Oral Contraceptive
arm group type: Experimental
intervention type: Drug
intervention name: EDP-305
description: Subjects will receive EDP-305 on on Days 11 through 21 of cycle 3
arm group label: EDP-305 and Oral Contraceptive
intervention type: Drug
intervention name: Oral Contraceptive
description: Subjects will receive active Oral Contraceptive on Days 1-21 and inert OC on Days 22-28 of cycles 1, 2 and 3
arm group label: EDP-305 and Oral Contraceptive
other name: ethinyl estradiol [EE] and norgestimate [NGM])
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Enanta Pharmaceuticals, Inc
role: Study Director
affiliation: Enanta Pharmaceuticals, Inc
facility: 
country: United States
responsible party type: Sponsor
mesh term: Fatty Liver
mesh term: Non-alcoholic Fatty Liver Disease
mesh term: Ethinyl Estradiol
mesh term: Norgestimate
mesh term: Contraceptive Agents
mesh term: Contraceptives, Oral
mesh term: Estradiol