<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/NCT03259542</url>
  </required_header>
  <id_info>
    <org_study_id>C1073-38</org_study_id>
    <nct_id>NCT03259542</nct_id>
  </id_info>
  <brief_title>Mifepristone Drug-Drug Interaction Study With CYP3A Inhibitor</brief_title>
  <official_title>A Phase 1, Open-Label, Drug-Drug Interaction Study in Healthy Subjects to Determine the Effects of a Strong Inhibitor (Itraconazole) of Cytochrome P450 3A on Exposure to Mifepristone and Its Metabolites</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Corcept Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Corcept Therapeutics</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>
      This is a Phase 1, single-center, fixed-sequence, open label, drug-drug interaction study of&#xD;
      the effect of multiple daily doses of oral itraconazole 200 mg, a strong inhibitor of CYP3A,&#xD;
      given with mifepristone 900 mg QD, in healthy male subjects, where all drug administrations&#xD;
      are given after a meal.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 9, 2017</start_date>
  <completion_date type="Actual">December 11, 2017</completion_date>
  <primary_completion_date type="Actual">December 11, 2017</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cmax of mifepristone at Day 42 compared to Day 28</measure>
    <time_frame>Day 42 compared to Day 28</time_frame>
    <description>Maximum (peak) plasma drug concentration (Cmax)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0-24 of mifepristone at Day 42 compared to Day 28</measure>
    <time_frame>Day 42 compared to Day 28</time_frame>
    <description>Area under the plasma concentration-time curve from zero to 24 hours (AUC0-24)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cmax of mifepristone at Day 42 compared to Day 14</measure>
    <time_frame>Day 42 compared to Day 14</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-24 of mifepristone compared to Day 14</measure>
    <time_frame>Day 42 compared to Day 14</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>T1/2 of mifepristone</measure>
    <time_frame>Days 14 and 28</time_frame>
    <description>Elimination half-life (T1/2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ctrough of mifepristone</measure>
    <time_frame>Days 1 through 28</time_frame>
    <description>Trough plasma concentration (measured concentration at the end of a dosing interval at steady state [taken directly before next administration]) (Ctrough)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Drug Interaction Potentiation</condition>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mifepristone 300 MG alone or Mifepristone 300 MG with Itraconazole 100 MG will be administered.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mifepristone 300 MG</intervention_name>
    <description>mifepristone 300 MG (4 tablets) orally for a total of 1200 mg a day for 14 days; then mifepristone 300 mg (3 tablets) orally for a total of 900 mg a day for 28 days</description>
    <arm_group_label>Arm 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Itraconazole 100 MG</intervention_name>
    <description>itraconazole 100 MG (2 capsules) orally for a total of 200 MG for the last 14 days of mifepristone dosing</description>
    <arm_group_label>Arm 1</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be healthy&#xD;
&#xD;
          -  Have a BMI of 18 to 32 kg/m2, inclusive and body weight more than 50 kg (110 pounds)&#xD;
&#xD;
          -  Be judged to be in good health, based on the results of medical history, physical&#xD;
             examination, vital signs, 12-lead ECG, and clinical laboratory findings&#xD;
&#xD;
          -  Have suitable veins for multiple venipuncture/cannulation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have multiple drug allergies, or be allergic to any of the components of mifepristone&#xD;
             or itraconazole&#xD;
&#xD;
          -  Have a condition that could be aggravated by glucocorticoid blockade (eg, asthma, any&#xD;
             chronic inflammatory condition)&#xD;
&#xD;
          -  In the 1 year before study drug administration, have a history of drug or alcohol&#xD;
             abuse&#xD;
&#xD;
          -  In the 6 calendar months before study drug administration, on average&#xD;
&#xD;
               -  Have smoked more than 5 cigarettes/day&#xD;
&#xD;
               -  Have consumed more than 21 units of alcohol/week (1 unit/drink = 5 ounces of&#xD;
                  wine, or 12 ounces of beer, or 1.5 ounces of hard liquor)&#xD;
&#xD;
          -  In 2 months prior to study drug administration, have donated/lost blood or plasma in&#xD;
             excess of 400 mL&#xD;
&#xD;
          -  In the 30 days before study drug administration, have participated in another clinical&#xD;
             trial of a new chemical entity or a prescription medicine&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Not based on self-representation of gender identity</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ada Lee, MD</last_name>
    <role>Study Director</role>
    <affiliation>Corcept Therapeutics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>SeaView Research</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33126</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>February 21, 2018</last_update_submitted>
  <last_update_submitted_qc>February 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 22, 2018</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>
    <mesh_term>Mifepristone</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/NCT03259542
org study id: C1073-38
nct id: NCT03259542
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a Phase 1, single-center, fixed-sequence, open label, drug-drug interaction study of
      the effect of multiple daily doses of oral itraconazole 200 mg, a strong inhibitor of CYP3A,
      given with mifepristone 900 mg QD, in healthy male subjects, where all drug administrations
      are given after a meal.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Cmax of mifepristone at Day 42 compared to Day 28
time frame: Day 42 compared to Day 28
description: Maximum (peak) plasma drug concentration (Cmax)
measure: AUC0-24 of mifepristone at Day 42 compared to Day 28
time frame: Day 42 compared to Day 28
description: Area under the plasma concentration-time curve from zero to 24 hours (AUC0-24)
measure: Cmax of mifepristone at Day 42 compared to Day 14
time frame: Day 42 compared to Day 14
measure: AUC0-24 of mifepristone compared to Day 14
time frame: Day 42 compared to Day 14
measure: T1/2 of mifepristone
time frame: Days 14 and 28
description: Elimination half-life (T1/2)
measure: Ctrough of mifepristone
time frame: Days 1 through 28
description: Trough plasma concentration (measured concentration at the end of a dosing interval at steady state [taken directly before next administration]) (Ctrough)
arm group label: Arm 1
arm group type: Experimental
description: Mifepristone 300 MG alone or Mifepristone 300 MG with Itraconazole 100 MG will be administered.
intervention type: Drug
intervention name: Mifepristone 300 MG
description: mifepristone 300 MG (4 tablets) orally for a total of 1200 mg a day for 14 days; then mifepristone 300 mg (3 tablets) orally for a total of 900 mg a day for 28 days
arm group label: Arm 1
intervention type: Drug
intervention name: Itraconazole 100 MG
description: itraconazole 100 MG (2 capsules) orally for a total of 200 MG for the last 14 days of mifepristone dosing
arm group label: Arm 1
criteria: 
gender: Male
gender based: Yes
gender description: Not based on self-representation of gender identity
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ada Lee, MD
role: Study Director
affiliation: Corcept Therapeutics
facility: 
country: United States
responsible party type: Sponsor
mesh term: Itraconazole
mesh term: Mifepristone