<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/NCT02975440</url>
  </required_header>
  <id_info>
    <org_study_id>17773</org_study_id>
    <nct_id>NCT02975440</nct_id>
  </id_info>
  <brief_title>Drug-drug Interaction Study Between Orally Administered Rifampicin and Vilaprisan</brief_title>
  <official_title>Non-randomized, Non-blinded, Non-placebo-controlled Study to Investigate the Influence of Repeated Daily Administration of 600 mg Rifampicin Given Once Daily Over 11 Days on the Pharmacokinetics, Safety, and Tolerability of a Single Oral Dose of 4 mg Vilaprisan in Healthy Postmenopausal Women.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bayer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will be conducted in a single center, open-label study with a single group fixed&#xD;
      sequence design to evaluate the effect of repeated oral administration of 600 mg&#xD;
      RIF(Rifampicin) given once daily over 11 days on the single oral dose pharmacokinetics of&#xD;
      VPR(Vilaprisan) and on MDZ(Midazolam) as a reference (probe) substance.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 10, 2016</start_date>
  <completion_date type="Actual">April 11, 2017</completion_date>
  <primary_completion_date type="Actual">January 27, 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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>AUC of Vilaprisan in plasma with co-medication Rifampicin</measure>
    <time_frame>blood sampling for pharmacokinetics of Vilaprisan (LC-MS/MS) at the following time points post administration of Vilaprisan and Midazolam: 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,15 hour, thereafter daily sampling up to 14 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax of Vilaprisan in plasma with co-medication Rifampicin</measure>
    <time_frame>blood sampling for pharmacokinetics of Vilaprisan (LC-MS/MS) at the following time points post administration of Vilaprisan and Midazolam: 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,15 hour, thereafter daily sampling up to 14 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC of Vilaprisan in plasma without co-medication Rifampicin</measure>
    <time_frame>blood sampling for pharmacokinetics of Vilaprisan (LC-MS/MS) at the following time points post administration of Vilaprisan and Midazolam: 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,15 hour, thereafter daily sampling up to 14 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax of Vilaprisan in plasma without co-medication Rifampicin</measure>
    <time_frame>blood sampling for pharmacokinetics of Vilaprisan (LC-MS/MS) at the following time points post administration of Vilaprisan and Midazolam: 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,15 hour, thereafter daily sampling up to 14 days</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Endometriosis</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment A (Period 1): a single oral dose of 4 mg Vilaprisan and 1 mg Midazolam Treatment B (Period 2): 600 mg Rifampicin once daily (qd) for 7 days followed by administration of a single oral dose of 4 mg Vilaprisan and 1 mg Midazolam followed by 600 mg Rifampicin 12 hours after Vilaprisan and Midazolam administration and continued dosing of 600 mg Rifampicin once daily for 3 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rifampicin</intervention_name>
    <description>11 single oral doses of 600 mg Rifampicin resulting in a total dose of 6600 mg Rifampicin.</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Midazolam</intervention_name>
    <description>2 single oral doses of 1 mg Midazolam resulting in a total dose of 2 mg Midazolam</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BAY1002670_Vilaprisan</intervention_name>
    <description>2 single oral doses of 4 mg Vilaprisan resulting in a total dose of 8 mg Vilaprisan</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy female postmenopausal subjects&#xD;
&#xD;
          -  Age: 45 to 65 years (inclusive)&#xD;
&#xD;
          -  Body mass index (BMI) : ≥20 and ≤32 kg/m²&#xD;
&#xD;
          -  Race: White&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any finding of the medical examination (including blood pressure, pulse rate and ECG)&#xD;
             deviating from normal and of clinical relevance&#xD;
&#xD;
          -  Relevant diseases within the last 4 weeks prior to the first drug administration&#xD;
&#xD;
          -  Existing chronic diseases requiring medication&#xD;
&#xD;
          -  Known or suspected malignant tumors (including history of malignant tumors, with a&#xD;
             status after treatment), known or suspected benign tumors of the liver and pituitary&#xD;
             (including after treatment)&#xD;
&#xD;
          -  Incompletely cured pre-existing diseases for which it can be assumed that the&#xD;
             absorption, distribution, metabolism, elimination and effects of the study drugs will&#xD;
             not be normal&#xD;
&#xD;
          -  Regular use of medicines&#xD;
&#xD;
          -  Repeated use of drugs during 1 week before first study drug administration which might&#xD;
             affect absorption (e.g. laxatives, loperamide, metoclopramide, antacids, H2-receptor&#xD;
             antagonists)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bayer Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Bayer</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>November 4, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>June 30, 2017</last_update_submitted>
  <last_update_submitted_qc>June 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Vilaprisan</keyword>
  <keyword>PK</keyword>
  <keyword>rifampicin</keyword>
  <keyword>midazolam,</keyword>
  <keyword>CYP3A4 induction</keyword>
  <keyword>drug-drug interaction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endometriosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rifampin</mesh_term>
    <mesh_term>Midazolam</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/NCT02975440
org study id: 17773
nct id: NCT02975440
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will be conducted in a single center, open-label study with a single group fixed
      sequence design to evaluate the effect of repeated oral administration of 600 mg
      RIF(Rifampicin) given once daily over 11 days on the single oral dose pharmacokinetics of
      VPR(Vilaprisan) and on MDZ(Midazolam) as a reference (probe) substance.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: AUC of Vilaprisan in plasma with co-medication Rifampicin
time frame: blood sampling for pharmacokinetics of Vilaprisan (LC-MS/MS) at the following time points post administration of Vilaprisan and Midazolam: 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,15 hour, thereafter daily sampling up to 14 days
measure: Cmax of Vilaprisan in plasma with co-medication Rifampicin
time frame: blood sampling for pharmacokinetics of Vilaprisan (LC-MS/MS) at the following time points post administration of Vilaprisan and Midazolam: 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,15 hour, thereafter daily sampling up to 14 days
measure: AUC of Vilaprisan in plasma without co-medication Rifampicin
time frame: blood sampling for pharmacokinetics of Vilaprisan (LC-MS/MS) at the following time points post administration of Vilaprisan and Midazolam: 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,15 hour, thereafter daily sampling up to 14 days
measure: Cmax of Vilaprisan in plasma without co-medication Rifampicin
time frame: blood sampling for pharmacokinetics of Vilaprisan (LC-MS/MS) at the following time points post administration of Vilaprisan and Midazolam: 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,15 hour, thereafter daily sampling up to 14 days
arm group label: Treatment
arm group type: Experimental
description: Treatment A (Period 1): a single oral dose of 4 mg Vilaprisan and 1 mg Midazolam Treatment B (Period 2): 600 mg Rifampicin once daily (qd) for 7 days followed by administration of a single oral dose of 4 mg Vilaprisan and 1 mg Midazolam followed by 600 mg Rifampicin 12 hours after Vilaprisan and Midazolam administration and continued dosing of 600 mg Rifampicin once daily for 3 days
intervention type: Drug
intervention name: Rifampicin
description: 11 single oral doses of 600 mg Rifampicin resulting in a total dose of 6600 mg Rifampicin.
arm group label: Treatment
intervention type: Drug
intervention name: Midazolam
description: 2 single oral doses of 1 mg Midazolam resulting in a total dose of 2 mg Midazolam
arm group label: Treatment
intervention type: Drug
intervention name: BAY1002670_Vilaprisan
description: 2 single oral doses of 4 mg Vilaprisan resulting in a total dose of 8 mg Vilaprisan
arm group label: Treatment
criteria: 
gender: Female
minimum age: 45 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Bayer Study Director
role: Study Director
affiliation: Bayer
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Endometriosis
mesh term: Rifampin
mesh term: Midazolam