<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/NCT02254148</url>
  </required_header>
  <id_info>
    <org_study_id>1307.19</org_study_id>
    <secondary_id>2013-005029-22</secondary_id>
    <nct_id>NCT02254148</nct_id>
  </id_info>
  <brief_title>The Effect of BI 187004 on the Pharmacokinetics of Cytochrome P450 Substrates (Caffeine, Warfarin, Omeprazole, Metoprolol and Midazolam) and a P Glycoprotein Substrate (Digoxin)</brief_title>
  <official_title>The Effect of Multiple Doses of BI 187004 on the Single Dose Pharmacokinetics of Cytochrome P450 Substrates (Caffeine, Warfarin, Omeprazole, Metoprolol and Midazolam) and a P-glycoprotein Substrate (Digoxin) Administered Orally in an Open-label, One-sequence Trial in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      To assess the influence of BI 187004 on kinetics of cytochrome P450 (CYP) and P glycoprotein&#xD;
      (P-gp) probe drugs as a means of predicting drug-drug interactions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>AUC0-tz (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) for probe substrates</measure>
    <time_frame>up to 143 hours postdose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax (Maximum measured concentration of the analyte in plasma) for probe substrates</measure>
    <time_frame>up to 143 hours postdose</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>single dose of CYP 450 substrates and a P-gp substrate + multiple doses of BI 187004</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>midazolam</intervention_name>
    <description>single dose of midazolam given as oral solution (day 1 of visits 2 and 3)</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>caffeine</intervention_name>
    <description>single dose of caffeine given as tablets (day 1 of visits 2 and 3)</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>digoxin</intervention_name>
    <description>single dose of digoxin given as tablets (day 3 of visits 2 and 3)</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>warfarin</intervention_name>
    <description>single dose of warfarin given as tablets (day 1 of visits 2 and 3)</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>omeprazole</intervention_name>
    <description>single dose of omeprazole given as tablet (day 1 of visits 2 and 3)</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 187004</intervention_name>
    <description>multiple doses of BI 187004 given as tablets (day 7-12 of visit 2 and day 1-6 of visit 3)</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>metoprolol</intervention_name>
    <description>single dose of metoprolol given as tablets (day 1 of visits 2 and 3)</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. healthy male subjects&#xD;
&#xD;
          2. age of 18 to 55 years&#xD;
&#xD;
          3. body mass index of 18.5 to 29.9 kg/m2&#xD;
&#xD;
          4. Subjects must be able to understand and comply with study requirements&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Any finding in the medical examination (including BP, PR or ECG) is deviating from&#xD;
             normal and judged as clinically relevant by the investigator&#xD;
&#xD;
          2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg,&#xD;
             diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the&#xD;
             range of 50 to 90 bpm&#xD;
&#xD;
          3. Any laboratory value outside the reference range that the investigator considers to be&#xD;
             of clinical relevance&#xD;
&#xD;
          4. Any evidence of a concomitant disease judged as clinically relevant by the&#xD;
             investigator&#xD;
&#xD;
          5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological or hormonal disorders&#xD;
&#xD;
          6. Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with&#xD;
             pharmacokinetics of the trial medication (except appendectomy and simple hernia&#xD;
             repair)&#xD;
&#xD;
          7. Diseases of the central nervous system (including but not limited to any kind of&#xD;
             seizures or stroke), and other relevant neurological or psychiatric disorders&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Boehringer Ingelheim</last_name>
    <role>Study Chair</role>
    <affiliation>Boehringer Ingelheim</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>1307.19.1 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Biberach</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>September 30, 2014</study_first_submitted>
  <study_first_submitted_qc>September 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>December 19, 2014</last_update_submitted>
  <last_update_submitted_qc>December 19, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 23, 2014</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>Metoprolol</mesh_term>
    <mesh_term>Digoxin</mesh_term>
    <mesh_term>Midazolam</mesh_term>
    <mesh_term>Caffeine</mesh_term>
    <mesh_term>Omeprazole</mesh_term>
    <mesh_term>Warfarin</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/NCT02254148
org study id: 1307.19
secondary id: 2013-005029-22
nct id: NCT02254148
lead sponsor: 
To assess the influence of BI 187004 on kinetics of cytochrome P450 (CYP) and P glycoprotein
      (P-gp) probe drugs as a means of predicting drug-drug interactions.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: AUC0-tz (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) for probe substrates
time frame: up to 143 hours postdose
measure: Cmax (Maximum measured concentration of the analyte in plasma) for probe substrates
time frame: up to 143 hours postdose
arm group label: Treatment
arm group type: Experimental
description: single dose of CYP 450 substrates and a P-gp substrate + multiple doses of BI 187004
intervention type: Drug
intervention name: midazolam
description: single dose of midazolam given as oral solution (day 1 of visits 2 and 3)
arm group label: Treatment
intervention type: Drug
intervention name: caffeine
description: single dose of caffeine given as tablets (day 1 of visits 2 and 3)
arm group label: Treatment
intervention type: Drug
intervention name: digoxin
description: single dose of digoxin given as tablets (day 3 of visits 2 and 3)
arm group label: Treatment
intervention type: Drug
intervention name: warfarin
description: single dose of warfarin given as tablets (day 1 of visits 2 and 3)
arm group label: Treatment
intervention type: Drug
intervention name: omeprazole
description: single dose of omeprazole given as tablet (day 1 of visits 2 and 3)
arm group label: Treatment
intervention type: Drug
intervention name: BI 187004
description: multiple doses of BI 187004 given as tablets (day 7-12 of visit 2 and day 1-6 of visit 3)
arm group label: Treatment
intervention type: Drug
intervention name: metoprolol
description: single dose of metoprolol given as tablets (day 1 of visits 2 and 3)
arm group label: Treatment
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Boehringer Ingelheim
role: Study Chair
affiliation: Boehringer Ingelheim
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Metoprolol
mesh term: Digoxin
mesh term: Midazolam
mesh term: Caffeine
mesh term: Omeprazole
mesh term: Warfarin