<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/NCT02254161</url>
  </required_header>
  <id_info>
    <org_study_id>1344.2</org_study_id>
    <secondary_id>2014-002482-30</secondary_id>
    <nct_id>NCT02254161</nct_id>
  </id_info>
  <brief_title>Multiple Rising Dose of BI 1181181 Given Orally in Young Healthy Male and Elderly Healthy Male/Female Volunteers</brief_title>
  <official_title>Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Rising Doses of BI 1181181 Given Orally q.d. for 10 Days in Young Healthy Male and Elderly Healthy Male/Female Volunteers (Randomized, Double-blind, Placebo Controlled Within Dose Groups Phase I Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      The primary objective of the current study is to investigate the safety and tolerability of&#xD;
      BI 1181181 in healthy young male and elderly male and female volunteers following oral&#xD;
      administration of repeated rising doses of BI 1181181, given once daily over 10 days.&#xD;
      Secondary objectives are the exploration of the pharmacokinetics (PK) and pharmacodynamics&#xD;
      (PD) of BI 1181181.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double</masking>
  </study_design_info>
  <primary_outcome>
    <measure>frequency [N (%)] of subjects with drug-related adverse events</measure>
    <time_frame>days 1 to 24</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t) after administration of the last dose</measure>
    <time_frame>0 to 336 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax,ss (maximum measured concentration of the analyte in CSF (if feasible) at steady state over a uniform dosing interval t) after administration of the last dose</measure>
    <time_frame>0 to 336 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUCt,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval t after administration of the first dose)</measure>
    <time_frame>0 to 336 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax (maximum measured concentration of the analyte in plasma) after administration of the first dose</measure>
    <time_frame>0 to 336 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t) after the administration of the last dose</measure>
    <time_frame>0 to 336 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUCt,ss (area under the concentration-time curve of the analyte in CSF (if feasible) at steady state over a uniform dosing interval t after the administration of the last dose</measure>
    <time_frame>0 to 336 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>BI 1181181 healthy young</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Medium doses as tablets q.d. for 10 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BI 1181181 healthy elderly</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Medium doses as tablets q.d. for 10 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Matching placebo in healthy young</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Matching placebo for 10 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Matching placebo in healthy elderly</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Matching placebo for 10 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Matching placebo</intervention_name>
    <description>Tablet</description>
    <arm_group_label>Matching placebo in healthy elderly</arm_group_label>
    <arm_group_label>Matching placebo in healthy young</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 1181181 healthy elderly</intervention_name>
    <description>Tablet</description>
    <arm_group_label>BI 1181181 healthy elderly</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 1181181 Healthy young</intervention_name>
    <description>Tablet</description>
    <arm_group_label>BI 1181181 healthy young</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. Healthy male or female subjects according to the investigator's assessment, based on a&#xD;
             complete medical history including a physical examination, vital signs (BP, PR),&#xD;
             12-lead ECG, and clinical laboratory tests.&#xD;
&#xD;
          2. Age of 18 to 50 years (incl.) for young healthy volunteers or of 65 to 80 years&#xD;
             (incl.) for elderly healthy volunteers.&#xD;
&#xD;
          3. BMI of 18.5 to 29.9 kg/m2 (incl.)&#xD;
&#xD;
          4. Signed and dated written informed consent prior to admission to the study in&#xD;
             accordance with GCP and local legislation.&#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. Any laboratory value outside the reference range that the investigator considers to be&#xD;
             of clinical relevance&#xD;
&#xD;
          3. Any evidence of a concomitant disease judged as clinically relevant by the&#xD;
             investigator&#xD;
&#xD;
          4. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological or hormonal disorders&#xD;
&#xD;
          5. Surgery of the gastrointestinal tract that could interfere with kinetics of the trial&#xD;
             medication (except appendectomy)&#xD;
&#xD;
          6. Diseases of the central nervous system (such as epilepsy), other neurological&#xD;
             disorders or psychiatric disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 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>1344.2.1 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2018</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>August 29, 2018</last_update_submitted>
  <last_update_submitted_qc>August 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02254161
org study id: 1344.2
secondary id: 2014-002482-30
nct id: NCT02254161
lead sponsor: 
The primary objective of the current study is to investigate the safety and tolerability of
      BI 1181181 in healthy young male and elderly male and female volunteers following oral
      administration of repeated rising doses of BI 1181181, given once daily over 10 days.
      Secondary objectives are the exploration of the pharmacokinetics (PK) and pharmacodynamics
      (PD) of BI 1181181.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Double
measure: frequency [N (%)] of subjects with drug-related adverse events
time frame: days 1 to 24
measure: Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t) after administration of the last dose
time frame: 0 to 336 hours
measure: Cmax,ss (maximum measured concentration of the analyte in CSF (if feasible) at steady state over a uniform dosing interval t) after administration of the last dose
time frame: 0 to 336 hours
measure: AUCt,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval t after administration of the first dose)
time frame: 0 to 336 hours
measure: Cmax (maximum measured concentration of the analyte in plasma) after administration of the first dose
time frame: 0 to 336 hours
measure: AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t) after the administration of the last dose
time frame: 0 to 336 hours
measure: AUCt,ss (area under the concentration-time curve of the analyte in CSF (if feasible) at steady state over a uniform dosing interval t after the administration of the last dose
time frame: 0 to 336 hours
arm group label: BI 1181181 healthy young
arm group type: Experimental
description: Medium doses as tablets q.d. for 10 days
arm group label: BI 1181181 healthy elderly
arm group type: Experimental
description: Medium doses as tablets q.d. for 10 days
arm group label: Matching placebo in healthy young
arm group type: Placebo Comparator
description: Matching placebo for 10 days
arm group label: Matching placebo in healthy elderly
arm group type: Placebo Comparator
description: Matching placebo for 10 days
intervention type: Drug
intervention name: Matching placebo
description: Tablet
arm group label: Matching placebo in healthy elderly
arm group label: Matching placebo in healthy young
intervention type: Drug
intervention name: BI 1181181 healthy elderly
description: Tablet
arm group label: BI 1181181 healthy elderly
intervention type: Drug
intervention name: BI 1181181 Healthy young
description: Tablet
arm group label: BI 1181181 healthy young
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Boehringer Ingelheim
role: Study Chair
affiliation: Boehringer Ingelheim
facility: 
country: Germany
responsible party type: Sponsor