<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/NCT02254122</url>
  </required_header>
  <id_info>
    <org_study_id>1205.2</org_study_id>
    <nct_id>NCT02254122</nct_id>
  </id_info>
  <brief_title>Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Inhalative Doses of BEA 2180 BR in Healthy Male Volunteers</brief_title>
  <official_title>Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Inhalative Doses (20 µg, 50 µg, 100 µg, 200 µg and 400 µg) of BEA 2180 BR for 21 Days in Healthy Male Volunteers (Double-blind, Randomised, Placebo Controlled [at Each Dose Level] 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>
      Study to investigate safety and tolerability, pharmacodynamics (PD) and pharmacokinetics (PK)&#xD;
      of BEA 2180 BR&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2004</start_date>
  <primary_completion_date type="Actual">February 2005</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of subjects with abnormal findings in physical examination</measure>
    <time_frame>up to day 42</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with clinically significant changes in vital signs</measure>
    <time_frame>up to day 42</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with clinically significant changes in 12-lead electrocardiogram</measure>
    <time_frame>up to day 42</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with clinically significant changes in laboratory parameters</measure>
    <time_frame>up to day 42</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in effective airway resistance (Reff)</measure>
    <time_frame>up to day 25</time_frame>
    <description>Body plethysmography</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in specific effective airway conductance (SGeff)</measure>
    <time_frame>up to day 25</time_frame>
    <description>Body plethysmography</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in salivary secretion</measure>
    <time_frame>up to day 21</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with adverse events</measure>
    <time_frame>up to day 42</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of tolerability by the Investigator on a 4-point rating scale</measure>
    <time_frame>day 42</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum concentration of the analyte in plasma for several time points</measure>
    <time_frame>up to day 35</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time from dosing to maximum concentration in plasma for several time points</measure>
    <time_frame>up to day 35</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration-time curve of the analyte in plasma for several time points</measure>
    <time_frame>up to day 35</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of analyte that is eliminated in urine for several time points</measure>
    <time_frame>up to day 34</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fraction of analyte excreted in urine for several time points</measure>
    <time_frame>up to day 34</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal clearance of the analyte in plasma for several time points</measure>
    <time_frame>up to day 34</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval</measure>
    <time_frame>up to day 35</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Predose concentration of the analyte in plasma at steady state immediately before administration of the next dose</measure>
    <time_frame>up to day 35</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal rate constant in plasma at steady state (λz,ss)</measure>
    <time_frame>up to day 35</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal half-life of the analyte in plasma at steady state (t1/2,ss)</measure>
    <time_frame>up to day 35</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean residence time of the analyte in the body after 21 administrations at steady state (MRTih,ss)</measure>
    <time_frame>up to day 35</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>apparent clearance of the analyte in the plasma after extravascular administration at steady state (CL/F,ss)</measure>
    <time_frame>up to day 35</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>apparent volume of distribution during the terminal phase λz following an extravascular dose at steady state (Vz/F,ss)</measure>
    <time_frame>up to day 35</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accumulation ratio (RA) of the analyte in plasma after multiple dose administration over a uniform dosing interval τ</measure>
    <time_frame>up to day 35</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak trough fluctuation (PTF)</measure>
    <time_frame>up to day 35</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">59</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>BEA 2180 BR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BEA 2180 BR</intervention_name>
    <arm_group_label>BEA 2180 BR</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Respimat®</intervention_name>
    <arm_group_label>BEA 2180 BR</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy males according to the following criteria (examined at the Screening Visit):&#xD;
&#xD;
             Based upon a complete medical history, including the physical examination, vital signs&#xD;
             (BP, PR), 12-lead ECG, clinical laboratory tests&#xD;
&#xD;
             1.1 No finding deviating from normal and of clinical relevance&#xD;
&#xD;
             1.2 No evidence of a clinically relevant concomitant disease&#xD;
&#xD;
          2. Age ≥30 and ≤55 years&#xD;
&#xD;
          3. BMI ≥18.5 and BMI &lt; 30 kg/m2 (Body Mass Index)&#xD;
&#xD;
          4. Signed and dated written informed consent prior to admission to the study in&#xD;
             accordance with Good Clinical Practice and the local legislation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological, or hormonal disorders&#xD;
&#xD;
          2. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or&#xD;
             neurological disorders&#xD;
&#xD;
          3. History of relevant orthostatic hypotension, fainting spells or blackouts&#xD;
&#xD;
          4. Chronic or relevant acute infections&#xD;
&#xD;
          5. History of allergy/hypersensitivity (including drug allergy) which is deemed relevant&#xD;
             to the trial as judged by the Investigator&#xD;
&#xD;
          6. Intake of drugs with a long half-life (&gt; 24 hours) within at least one month or less&#xD;
             than 10 half-lives of the respective drug prior to administration or during the trial&#xD;
&#xD;
          7. Use of drugs which might reasonably influence the results of the trial based on the&#xD;
             knowledge at the time of protocol preparation within 10 days prior to administration&#xD;
             or during the trial&#xD;
&#xD;
          8. Participation in another trial with an investigational drug within two months prior to&#xD;
             administration or during the trial&#xD;
&#xD;
          9. Smoker (&gt; 10 cigarettes or &gt; 3 cigars or &gt; 3 pipes/day)&#xD;
&#xD;
         10. Inability to refrain from smoking during the trial&#xD;
&#xD;
         11. Alcohol abuse (more than 60 g/day)&#xD;
&#xD;
         12. Drug abuse&#xD;
&#xD;
         13. Blood donation (more than 100 mL within four weeks prior to administration or during&#xD;
             the trial)&#xD;
&#xD;
         14. Excessive physical activities (within one week prior to administration or during the&#xD;
             trial)&#xD;
&#xD;
         15. Any laboratory value outside the reference range if indicative of underlying disease&#xD;
             or poor health&#xD;
&#xD;
        Exclusion criteria specific for this study:&#xD;
&#xD;
          -  Asthma or chronic obstructive pulmonary disease&#xD;
&#xD;
          -  Glaucoma&#xD;
&#xD;
          -  Urinary tract obstruction&#xD;
&#xD;
          -  Occupational (professional) exposure to antimuscarinic substances&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>September 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>September 30, 2014</last_update_submitted>
  <last_update_submitted_qc>September 30, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 1, 2014</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/NCT02254122
org study id: 1205.2
nct id: NCT02254122
lead sponsor: 
Study to investigate safety and tolerability, pharmacodynamics (PD) and pharmacokinetics (PK)
      of BEA 2180 BR
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Number of subjects with abnormal findings in physical examination
time frame: up to day 42
measure: Number of subjects with clinically significant changes in vital signs
time frame: up to day 42
measure: Number of subjects with clinically significant changes in 12-lead electrocardiogram
time frame: up to day 42
measure: Number of subjects with clinically significant changes in laboratory parameters
time frame: up to day 42
measure: Changes in effective airway resistance (Reff)
time frame: up to day 25
description: Body plethysmography
measure: Changes in specific effective airway conductance (SGeff)
time frame: up to day 25
description: Body plethysmography
measure: Changes in salivary secretion
time frame: up to day 21
measure: Number of subjects with adverse events
time frame: up to day 42
measure: Assessment of tolerability by the Investigator on a 4-point rating scale
time frame: day 42
measure: Maximum concentration of the analyte in plasma for several time points
time frame: up to day 35
measure: Time from dosing to maximum concentration in plasma for several time points
time frame: up to day 35
measure: Area under the concentration-time curve of the analyte in plasma for several time points
time frame: up to day 35
measure: Amount of analyte that is eliminated in urine for several time points
time frame: up to day 34
measure: Fraction of analyte excreted in urine for several time points
time frame: up to day 34
measure: Renal clearance of the analyte in plasma for several time points
time frame: up to day 34
measure: Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval
time frame: up to day 35
measure: Predose concentration of the analyte in plasma at steady state immediately before administration of the next dose
time frame: up to day 35
measure: Terminal rate constant in plasma at steady state (λz,ss)
time frame: up to day 35
measure: Terminal half-life of the analyte in plasma at steady state (t1/2,ss)
time frame: up to day 35
measure: Mean residence time of the analyte in the body after 21 administrations at steady state (MRTih,ss)
time frame: up to day 35
measure: apparent clearance of the analyte in the plasma after extravascular administration at steady state (CL/F,ss)
time frame: up to day 35
measure: apparent volume of distribution during the terminal phase λz following an extravascular dose at steady state (Vz/F,ss)
time frame: up to day 35
measure: Accumulation ratio (RA) of the analyte in plasma after multiple dose administration over a uniform dosing interval τ
time frame: up to day 35
measure: Peak trough fluctuation (PTF)
time frame: up to day 35
arm group label: BEA 2180 BR
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: BEA 2180 BR
arm group label: BEA 2180 BR
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
intervention type: Device
intervention name: Respimat®
arm group label: BEA 2180 BR
arm group label: Placebo
criteria: 
gender: Male
minimum age: 30 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor