<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/NCT03258372</url>
  </required_header>
  <id_info>
    <org_study_id>C1073-37</org_study_id>
    <nct_id>NCT03258372</nct_id>
  </id_info>
  <brief_title>Crossover Drug-Drug Interaction Study to Determine Effects of Cytochrome P450 3A on Exposure to Mifepristone and Its Metabolites</brief_title>
  <official_title>A Phase 1, Open-Label, Fixed-Sequence, Crossover Drug-Drug Interaction Study in Healthy Subjects to Determine the Effects of a Strong Inducer 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 doses of rifampin 600 mg daily, a strong CYP3A inducer, on the&#xD;
      exposure of mifepristone at 2 dose levels.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 16, 2017</start_date>
  <completion_date type="Actual">November 29, 2017</completion_date>
  <primary_completion_date type="Actual">November 29, 2017</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cmax of mifepristone of period 1 vs Cmax of mifepristone of period 3</measure>
    <time_frame>18 days</time_frame>
    <description>Maximum (peak) plasma drug concentration (Cmax)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0-tz of mifepristone of period 1 vs AUC0-tz of mifepristone of period 3</measure>
    <time_frame>18 days</time_frame>
    <description>Area under the concentration-time curve from zero up to the last concentration above the lower limit of quantification of the assay (AUC0-tz)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUCinf of mifepristone of period 1 vs AUCinf of mifepristone of period 3</measure>
    <time_frame>18 days</time_frame>
    <description>Area under the plasma concentration-time curve from time zero to infinity (AUCinf)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cmax of mifepristone metabolites of period 1 vs Cmax of mifepristone metabolites of period 3</measure>
    <time_frame>18 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-tz of mifepristone metabolites of period 1 vs AUC0-tz of mifepristone metabolites of period 3</measure>
    <time_frame>18 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUCinf of mifepristone metabolites of period 1 vs AUCinf of minfepristone metabolites of period 3</measure>
    <time_frame>18 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Cohort 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mifepristone 300 MG, 1 tablet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mifepristone 1500 MG, 5 tablets</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mifepristone</intervention_name>
    <description>Period 1: mifepristone 300 MG (1 tablet) for a total of 300 MG on Day 1 in Cohort 1; and mifepristone 300 MG (5 tablets) for a total of 1500 MG in Cohort 2; then Period 2: rifampin 300 MG (2 capsules) for a total of 600 MG daily for 14 days for both cohorts; then Period 3: mifepristone 300 MG (1 tablet) for a total of 300 MG on Day 1 in Cohort 1; and mifepristone 300 MG (5 tablets) for a total of 1500 MG in Cohort 2</description>
    <arm_group_label>Cohort 1</arm_group_label>
    <arm_group_label>Cohort 2</arm_group_label>
    <other_name>rifampin</other_name>
  </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;
          -  Female subjects of childbearing potential must use highly effective contraception with&#xD;
             low user-dependency. The only acceptable method is an intrauterine device (IUD),&#xD;
             provided that the subject has tolerated its use for at least 3 months before the first&#xD;
             dose of study drug and undertakes not to have it removed for 1 month after the last&#xD;
             dose of study drug. Use of hormonal contraception (by any route, including&#xD;
             intrauterine hormone releasing systems) or hormone replacement therapy is NOT&#xD;
             acceptable.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have multiple drug allergies, or be allergic to any of the components of mifepristone&#xD;
             or rifampin&#xD;
&#xD;
          -  Have a condition that could be aggravated by glucocorticoid blockade (eg, asthma, any&#xD;
             chronic inflammatory condition)&#xD;
&#xD;
          -  Have a history of unexplained vaginal bleeding, endometrial hyperplasia with atypia or&#xD;
             endometrial carcinoma&#xD;
&#xD;
          -  Breastfeeding&#xD;
&#xD;
          -  In the 1 year before first study drug administration, have a history of drug or&#xD;
             alcohol abuse&#xD;
&#xD;
          -  In the 6 calendar months before first 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 for male subjects or 14 units&#xD;
                  for female subjects (1 unit/drink = 5 ounces of wine, or 12 ounces of beer, or&#xD;
                  1.5 ounces of hard liquor)&#xD;
&#xD;
          -  In the 2 calendar months before first study drug administration, have donated/lost&#xD;
             blood or plasma in excess of 400 mL&#xD;
&#xD;
          -  In the 30 days before first study drug administration, have participated in another&#xD;
             clinical trial of a new chemical entity or a prescription medicine&#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>Ada Lee, MD</last_name>
    <role>Study Director</role>
    <affiliation>Corcept Therapeutics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>SeaView Reserch</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>November 2017</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 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 23, 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>Rifampin</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/NCT03258372
org study id: C1073-37
nct id: NCT03258372
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 doses of rifampin 600 mg daily, a strong CYP3A inducer, on the
      exposure of mifepristone at 2 dose levels.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: Cmax of mifepristone of period 1 vs Cmax of mifepristone of period 3
time frame: 18 days
description: Maximum (peak) plasma drug concentration (Cmax)
measure: AUC0-tz of mifepristone of period 1 vs AUC0-tz of mifepristone of period 3
time frame: 18 days
description: Area under the concentration-time curve from zero up to the last concentration above the lower limit of quantification of the assay (AUC0-tz)
measure: AUCinf of mifepristone of period 1 vs AUCinf of mifepristone of period 3
time frame: 18 days
description: Area under the plasma concentration-time curve from time zero to infinity (AUCinf)
measure: Cmax of mifepristone metabolites of period 1 vs Cmax of mifepristone metabolites of period 3
time frame: 18 days
measure: AUC0-tz of mifepristone metabolites of period 1 vs AUC0-tz of mifepristone metabolites of period 3
time frame: 18 days
measure: AUCinf of mifepristone metabolites of period 1 vs AUCinf of minfepristone metabolites of period 3
time frame: 18 days
arm group label: Cohort 1
arm group type: Experimental
description: Mifepristone 300 MG, 1 tablet
arm group label: Cohort 2
arm group type: Experimental
description: Mifepristone 1500 MG, 5 tablets
intervention type: Drug
intervention name: Mifepristone
description: Period 1: mifepristone 300 MG (1 tablet) for a total of 300 MG on Day 1 in Cohort 1; and mifepristone 300 MG (5 tablets) for a total of 1500 MG in Cohort 2; then Period 2: rifampin 300 MG (2 capsules) for a total of 600 MG daily for 14 days for both cohorts; then Period 3: mifepristone 300 MG (1 tablet) for a total of 300 MG on Day 1 in Cohort 1; and mifepristone 300 MG (5 tablets) for a total of 1500 MG in Cohort 2
arm group label: Cohort 1
arm group label: Cohort 2
other name: rifampin
criteria: 
gender: All
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: Rifampin
mesh term: Mifepristone