<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/NCT03748628</url>
  </required_header>
  <id_info>
    <org_study_id>EDP 305-009</org_study_id>
    <nct_id>NCT03748628</nct_id>
  </id_info>
  <brief_title>Absorption, Metabolism and Excretion (AME) Study of [14C]EDP-305 in Healthy Male Subjects</brief_title>
  <official_title>A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]EDP-305 Following a Single Oral Dose in Healthy Male Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Enanta Pharmaceuticals, Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </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 Study of the absorption, metabolism, and excretion of a single oral&#xD;
      dose of [14C]EDP-305 in healthy male subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 5, 2018</start_date>
  <completion_date type="Actual">October 13, 2018</completion_date>
  <primary_completion_date type="Actual">October 13, 2018</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>Cmax of EDP-305 in plasma</measure>
    <time_frame>Up to 9 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC of EDP-305 in plasma</measure>
    <time_frame>Up to 9 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC-inf in plasma</measure>
    <time_frame>Up to 9 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Amount excreted in urine (Aeu)</measure>
    <time_frame>Up to 9 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount excreted in feces (Aef)</measure>
    <time_frame>Up to 9 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety measured by adverse events</measure>
    <time_frame>Up to 9 days</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>NASH - Nonalcoholic Steatohepatitis</condition>
  <arm_group>
    <arm_group_label>Single arm EDP-305</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>[14C]EDP-305</description>
    <arm_group_label>Single arm EDP-305</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male subjects aged between 18 and 55 years (inclusive) with a body mass index&#xD;
             between 18.0 and 32.0 kg/m2 (inclusive)&#xD;
&#xD;
          -  able to comprehend and willing to sign an Informed Consent Form&#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.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant history or clinical manifestation of any metabolic, allergic,&#xD;
             dermatological, hepatic, renal, hematological, pulmonary, cardiovascular,&#xD;
             gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as&#xD;
             determined by the Investigator (or designee).&#xD;
&#xD;
          -  History of stomach or intestinal surgery or resection that would potentially alter&#xD;
             absorption and/or excretion of orally administered drugs (including gastrectomy and&#xD;
             cholecystectomy; uncomplicated appendectomy and hernia repair will be allowed).&#xD;
&#xD;
          -  Donation of blood from 56 days prior to Screening, plasma from 2 weeks prior to&#xD;
             Screening, or platelets from 6 weeks prior to Screening.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <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, 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>October 2018</verification_date>
  <study_first_submitted>October 31, 2018</study_first_submitted>
  <study_first_submitted_qc>November 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>November 18, 2018</last_update_submitted>
  <last_update_submitted_qc>November 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>AME Study</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>
  <!-- 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/NCT03748628
org study id: EDP 305-009
nct id: NCT03748628
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
A Phase 1, Open-label Study of the absorption, metabolism, and excretion of a single oral
      dose of [14C]EDP-305 in healthy male subjects.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Cmax of EDP-305 in plasma
time frame: Up to 9 days
measure: AUC of EDP-305 in plasma
time frame: Up to 9 days
measure: AUC-inf in plasma
time frame: Up to 9 days
measure: Amount excreted in urine (Aeu)
time frame: Up to 9 days
measure: Amount excreted in feces (Aef)
time frame: Up to 9 days
measure: Safety measured by adverse events
time frame: Up to 9 days
arm group label: Single arm EDP-305
arm group type: Experimental
intervention type: Drug
intervention name: EDP-305
description: [14C]EDP-305
arm group label: Single arm EDP-305
criteria: 
gender: Male
gender based: Yes
minimum age: 18 Years
maximum age: 55 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