<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/NCT03792139</url>
  </required_header>
  <id_info>
    <org_study_id>16616</org_study_id>
    <secondary_id>I8X-MC-JECC</secondary_id>
    <nct_id>NCT03792139</nct_id>
  </id_info>
  <brief_title>An Interaction Study of LY3200882 in Healthy Participants</brief_title>
  <official_title>Effects of CYP3A4 Inhibition by Itraconazole on the Pharmacokinetics of LY3200882 in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eli Lilly and Company</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>
      The main purpose of this study is to evaluate the effect of itraconazole on the amount of&#xD;
      LY3200882 in the blood stream and how long the body takes to get rid of LY3200882. The safety&#xD;
      and tolerability of LY3200882 when given with itraconazole will be evaluated. The study is&#xD;
      expected to last up to 19 days from the first dose to follow-up (inclusive). Screening will&#xD;
      occur up to 28 days prior to enrollment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 8, 2019</start_date>
  <completion_date type="Actual">February 23, 2019</completion_date>
  <primary_completion_date type="Actual">February 23, 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>Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3200882</measure>
    <time_frame>Baseline through 72 hours post-dose</time_frame>
    <description>PK: Cmax of LY3200882</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PK: Area Under the Concentration Curve (AUC) of LY3200882</measure>
    <time_frame>Baseline through 72 hours post-dose</time_frame>
    <description>PK: AUC of LY3200882</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>LY3200882</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LY3200882 administered orally.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Itraconazole + LY3200882</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Itraconazole + LY3200882 administered orally.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LY3200882</intervention_name>
    <description>Administered orally.</description>
    <arm_group_label>Itraconazole + LY3200882</arm_group_label>
    <arm_group_label>LY3200882</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Itraconazole</intervention_name>
    <description>Administered orally.</description>
    <arm_group_label>Itraconazole + LY3200882</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy males or postmenopausal females, as determined by medical history and physical&#xD;
             examination&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have a history or presence of cardiovascular, respiratory, hepatic, renal,&#xD;
             gastrointestinal, endocrine, hematological, or neurological disorders capable of&#xD;
             significantly altering the absorption, metabolism, or elimination of drugs; of&#xD;
             constituting a risk when taking the study medication; or of interfering with the&#xD;
             interpretation of data&#xD;
&#xD;
          -  Have used or intend to use over-the-counter or prescription medication including&#xD;
             herbal medications within 14 days prior to dosing and during the study (with the&#xD;
             exception of vitamins and occasional acetaminophen or ibuprofen, which will be&#xD;
             permitted at the discretion of the investigator). Drugs that are known substrates,&#xD;
             inducers, or inhibitors of CYP3A4 are specifically excluded within 30 days of dosing&#xD;
             and throughout the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)</last_name>
    <role>Study Director</role>
    <affiliation>Eli Lilly and Company</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Covance Clinical Research Inc</name>
      <address>
        <city>Daytona Beach</city>
        <state>Florida</state>
        <zip>32117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>March 7, 2019</last_update_submitted>
  <last_update_submitted_qc>March 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Itraconazole</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03792139
org study id: 16616
secondary id: I8X-MC-JECC
nct id: NCT03792139
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The main purpose of this study is to evaluate the effect of itraconazole on the amount of
      LY3200882 in the blood stream and how long the body takes to get rid of LY3200882. The safety
      and tolerability of LY3200882 when given with itraconazole will be evaluated. The study is
      expected to last up to 19 days from the first dose to follow-up (inclusive). Screening will
      occur up to 28 days prior to enrollment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3200882
time frame: Baseline through 72 hours post-dose
description: PK: Cmax of LY3200882
measure: PK: Area Under the Concentration Curve (AUC) of LY3200882
time frame: Baseline through 72 hours post-dose
description: PK: AUC of LY3200882
arm group label: LY3200882
arm group type: Experimental
description: LY3200882 administered orally.
arm group label: Itraconazole + LY3200882
arm group type: Experimental
description: Itraconazole + LY3200882 administered orally.
intervention type: Drug
intervention name: LY3200882
description: Administered orally.
arm group label: Itraconazole + LY3200882
arm group label: LY3200882
intervention type: Drug
intervention name: Itraconazole
description: Administered orally.
arm group label: Itraconazole + LY3200882
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: Study Director
affiliation: Eli Lilly and Company
facility: 
country: United States
responsible party type: Sponsor
mesh term: Itraconazole
sharing ipd: No