<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/NCT02255968</url>
  </required_header>
  <id_info>
    <org_study_id>EDP788-002</org_study_id>
    <nct_id>NCT02255968</nct_id>
  </id_info>
  <brief_title>Evaluation of the Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of EDP-788</brief_title>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple-Dose Safety, Tolerability, and Pharmacokinetic Study of EDP-788 in Healthy Adult Volunteers</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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of the study is to determine the safety and tolerability of multiple&#xD;
      doses of orally administered EDP-788. Secondary objectives of the study are to describe the&#xD;
      pharmacokinetics of EDP-788 (and its metabolite EDP-322) after multiple doses of orally&#xD;
      administered drug.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Three cohorts of subjects will be enrolled to receive either EDP-788 or placebo. The dose of&#xD;
      EDP-788 will be increased with each successive cohort. In addition, a 4th cohort may be&#xD;
      enrolled, depending on clinical findings (tolerability, safety, pharmacokinetics) observed in&#xD;
      the first 3 cohorts. In each cohort, 8 subjects will receive a q12h oral dose regimen of&#xD;
      EDP-788 (6 subjects) or placebo (2 subjects). All subjects receive multiple doses of study&#xD;
      drug (EDP-788 or placebo).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence and severity of adverse events</measure>
    <time_frame>From time of dosing to 20-23 days after receiving last dose of study drug</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in laboratory values and vital signs</measure>
    <time_frame>From time of dosing to 20-23 days after receiving last dose of study drug</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic parameters</measure>
    <time_frame>From time of dosing to 3 days after receiving the last dose of study drug</time_frame>
    <description>As measured by peak plasma concentration (Cmax)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>EDP-788</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Multiple doses with dose escalation to continue in successive cohorts</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Multiple doses with dose escalation to continue in successive cohorts</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>EDP-788</intervention_name>
    <description>EDP-788 Capsules. All interventions are given as multiple doses.</description>
    <arm_group_label>EDP-788</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Matching placebo capsules. All interventions are given as multiple doses</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  In good general health&#xD;
&#xD;
          -  BMI between 18 - 32 kg/m2&#xD;
&#xD;
          -  Women must be of non-childbearing potential (surgically sterilized)&#xD;
&#xD;
          -  Normal electrocardiogram&#xD;
&#xD;
          -  Willing to abstain from strenuous physical exercise starting 3 days prior to admission&#xD;
             to the study clinic through the 17 - 19 day post-dosing visit&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Hypersensitivity to macrolide antibiotics&#xD;
&#xD;
          -  Abnormal laboratory values&#xD;
&#xD;
          -  Gastroenteritis within 1 week of study drug administration&#xD;
&#xD;
          -  Use of any investigational drugs within 28 days of study drug administration&#xD;
&#xD;
          -  History of gastrointestinal surgery which may interfere with drug absorption&#xD;
&#xD;
          -  Active Hepatitis B, Hepatitis C, or HIV infection&#xD;
&#xD;
          -  Use of prescription or non-prescription drugs within 14 days of study drug&#xD;
             administration&#xD;
&#xD;
          -  Use of nicotine within 3 months of study drug administration&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>PPD Phase 1 Clinic</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78744</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>October 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2014</study_first_posted>
  <last_update_submitted>May 8, 2015</last_update_submitted>
  <last_update_submitted_qc>May 8, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 12, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Normal Volunteers</keyword>
  <keyword>Safety</keyword>
  <keyword>Pharmacokinetics</keyword>
  <!-- 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/NCT02255968
org study id: EDP788-002
nct id: NCT02255968
lead sponsor: 
has dmc: Yes
The primary objective of the study is to determine the safety and tolerability of multiple
      doses of orally administered EDP-788. Secondary objectives of the study are to describe the
      pharmacokinetics of EDP-788 (and its metabolite EDP-322) after multiple doses of orally
      administered drug.
Three cohorts of subjects will be enrolled to receive either EDP-788 or placebo. The dose of
      EDP-788 will be increased with each successive cohort. In addition, a 4th cohort may be
      enrolled, depending on clinical findings (tolerability, safety, pharmacokinetics) observed in
      the first 3 cohorts. In each cohort, 8 subjects will receive a q12h oral dose regimen of
      EDP-788 (6 subjects) or placebo (2 subjects). All subjects receive multiple doses of study
      drug (EDP-788 or placebo).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Incidence and severity of adverse events
time frame: From time of dosing to 20-23 days after receiving last dose of study drug
measure: Changes from baseline in laboratory values and vital signs
time frame: From time of dosing to 20-23 days after receiving last dose of study drug
measure: Pharmacokinetic parameters
time frame: From time of dosing to 3 days after receiving the last dose of study drug
description: As measured by peak plasma concentration (Cmax)
arm group label: EDP-788
arm group type: Experimental
description: Multiple doses with dose escalation to continue in successive cohorts
arm group label: Placebo
arm group type: Placebo Comparator
description: Multiple doses with dose escalation to continue in successive cohorts
intervention type: Drug
intervention name: EDP-788
description: EDP-788 Capsules. All interventions are given as multiple doses.
arm group label: EDP-788
intervention type: Drug
intervention name: Placebo
description: Matching placebo capsules. All interventions are given as multiple doses
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor