<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/NCT02254720</url>
  </required_header>
  <id_info>
    <org_study_id>1205.5</org_study_id>
    <nct_id>NCT02254720</nct_id>
  </id_info>
  <brief_title>Safety, Tolerability and Pharmacokinetics of BEA 2180 BR in Healthy Male Volunteers</brief_title>
  <official_title>A Randomised, Single-blind, Placebo-controlled (Within Dose Groups) Study to Assess Safety, Tolerability and Pharmacokinetics of Single Rising Intravenous Doses (2.5 μg, 7.5 μg, 25 μg, 50 μg, 100 μg, 200 μg, 350 μg, 500 μg Free Cation) BEA 2180 BR in Healthy Male Volunteers With an Additional Arm by Inhalation in One Dose Group (1600 μg)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Evaluation of safety, tolerability and pharmacokinetics of single rising intravenous doses of&#xD;
      BEA 2180 BR; additional exploration of metabolism following inhalation&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2006</start_date>
  <primary_completion_date type="Actual">December 2006</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>Single</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with abnormal findings in physical examination</measure>
    <time_frame>Up to day 12 after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with clinically significant changes in vital signs</measure>
    <time_frame>Up to day 12 after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with abnormal findings in 12 - lead ECG (electrocardiogram)</measure>
    <time_frame>Up to day 12 after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with abnormal changes in clinical laboratory parameters</measure>
    <time_frame>Up to day 12 after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with adverse events</measure>
    <time_frame>Up to day 12 after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Investigator assessed tolerability on a 4-point scale</measure>
    <time_frame>Up to day 12 after drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cmax (maximum measured concentration of the analyte in plasma)</measure>
    <time_frame>Up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tmax (time from dosing to maximum measured concentration)</measure>
    <time_frame>Up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)</measure>
    <time_frame>Up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>%AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation)</measure>
    <time_frame>Up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)</measure>
    <time_frame>Up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>λz (terminal rate constant in plasma)</measure>
    <time_frame>Up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2 (terminal half-life of the analyte in plasma)</measure>
    <time_frame>Up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRT(mean residence time of the analyte in the body)</measure>
    <time_frame>Up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL (total clearance of the analyte in plasma)</measure>
    <time_frame>Up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vz (apparent volume of distribution during the terminal phase λz)</measure>
    <time_frame>Up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vss (apparent volume of distribution at steady state following intravascular administration)</measure>
    <time_frame>Up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)</measure>
    <time_frame>Up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)</measure>
    <time_frame>Up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)</measure>
    <time_frame>Up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">71</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>BEA 2180 BR IV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Rising doses</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>BEA 2180 BR inhalation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BEA 2180 BR solution for infusion</intervention_name>
    <arm_group_label>BEA 2180 BR IV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Intravenous infusion</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BEA 2180 BR solution for inhalation</intervention_name>
    <arm_group_label>BEA 2180 BR inhalation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Respimat®</intervention_name>
    <arm_group_label>BEA 2180 BR inhalation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy male based upon a complete medical history, including the physical&#xD;
             examination, regarding vital signs (BP, PR), 12 lead ECG measurement, and clinical&#xD;
             laboratory tests. There is no finding deviating from normal and of clinical relevance.&#xD;
             There is no evidence of a clinically relevant concomitant disease.&#xD;
&#xD;
          2. Age ≥21 and ≤50 years&#xD;
&#xD;
          3. BMI ≥18.5 and &lt;29.9 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 (GCP) and the local legislation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any finding of the medical examination (including blood pressure (BP), pulse rate&#xD;
             (PR), and ECG measurements) deviating from normal and of clinical relevance&#xD;
&#xD;
          2. Evidence of a clinically relevant concomitant disease&#xD;
&#xD;
          3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological or hormonal disorders&#xD;
&#xD;
          4. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or&#xD;
             neurological disorders&#xD;
&#xD;
          5. History of relevant orthostatic hypotension, fainting spells or blackouts&#xD;
&#xD;
          6. Chronic or relevant acute infections&#xD;
&#xD;
          7. History of relevant allergy/hypersensitivity (including allergy to the drug or its&#xD;
             excipients) as judged clinically relevant by the investigator&#xD;
&#xD;
          8. Intake of drugs with a long half-life (&gt;24 hours) within at least 1 month or less than&#xD;
             10 half-lives of the respective drug prior to randomisation&#xD;
&#xD;
          9. 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 enrolment in the&#xD;
             study or during the study&#xD;
&#xD;
         10. Participation in another trial with an investigational drug within 2 months prior to&#xD;
             randomisation&#xD;
&#xD;
         11. Smoker (&gt;10 cigarettes or &gt;3 cigars or &gt;3 pipes/day)&#xD;
&#xD;
         12. Inability to refrain from smoking on trial days as judged by the investigator&#xD;
&#xD;
         13. Alcohol abuse (regularly more than 40 g alcohol per day for men)&#xD;
&#xD;
         14. Drug abuse&#xD;
&#xD;
         15. Blood donation (more than 100 mL blood within 4 weeks prior to randomisation or during&#xD;
             the trial)&#xD;
&#xD;
         16. Excessive physical activities within 1 week prior to randomisation or during the trial&#xD;
&#xD;
         17. Any laboratory value outside the reference range that is of clinical relevance&#xD;
&#xD;
         18. Inability to comply with dietary regimen of the study centre&#xD;
&#xD;
             The following exclusion criteria are specific for this study due to the known class&#xD;
             side effect profile of anticholinergic drugs:&#xD;
&#xD;
         19. hypersensitivity to tiotropium and/or related drugs of these classes&#xD;
&#xD;
         20. history of narrow-angle glaucoma&#xD;
&#xD;
         21. history of prostatic hyperplasia&#xD;
&#xD;
         22. history of bladder-neck obstruction&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>50 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>October 1, 2014</study_first_submitted>
  <study_first_submitted_qc>October 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <last_update_submitted>October 1, 2014</last_update_submitted>
  <last_update_submitted_qc>October 1, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 2, 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>Pharmaceutical Solutions</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/NCT02254720
org study id: 1205.5
nct id: NCT02254720
lead sponsor: 
Evaluation of safety, tolerability and pharmacokinetics of single rising intravenous doses of
      BEA 2180 BR; additional exploration of metabolism following inhalation
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single
measure: Number of participants with abnormal findings in physical examination
time frame: Up to day 12 after drug administration
measure: Number of participants with clinically significant changes in vital signs
time frame: Up to day 12 after drug administration
measure: Number of participants with abnormal findings in 12 - lead ECG (electrocardiogram)
time frame: Up to day 12 after drug administration
measure: Number of participants with abnormal changes in clinical laboratory parameters
time frame: Up to day 12 after drug administration
measure: Number of participants with adverse events
time frame: Up to day 12 after drug administration
measure: Investigator assessed tolerability on a 4-point scale
time frame: Up to day 12 after drug administration
measure: Cmax (maximum measured concentration of the analyte in plasma)
time frame: Up to 72 hours after drug administration
measure: tmax (time from dosing to maximum measured concentration)
time frame: Up to 72 hours after drug administration
measure: AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
time frame: Up to 72 hours after drug administration
measure: %AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation)
time frame: Up to 72 hours after drug administration
measure: AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
time frame: Up to 72 hours after drug administration
measure: λz (terminal rate constant in plasma)
time frame: Up to 72 hours after drug administration
measure: t1/2 (terminal half-life of the analyte in plasma)
time frame: Up to 72 hours after drug administration
measure: MRT(mean residence time of the analyte in the body)
time frame: Up to 72 hours after drug administration
measure: CL (total clearance of the analyte in plasma)
time frame: Up to 72 hours after drug administration
measure: Vz (apparent volume of distribution during the terminal phase λz)
time frame: Up to 72 hours after drug administration
measure: Vss (apparent volume of distribution at steady state following intravascular administration)
time frame: Up to 72 hours after drug administration
measure: Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)
time frame: Up to 72 hours after drug administration
measure: fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)
time frame: Up to 72 hours after drug administration
measure: CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)
time frame: Up to 72 hours after drug administration
arm group label: BEA 2180 BR IV
arm group type: Experimental
description: Rising doses
arm group label: Placebo
arm group type: Placebo Comparator
arm group label: BEA 2180 BR inhalation
arm group type: Experimental
intervention type: Drug
intervention name: BEA 2180 BR solution for infusion
arm group label: BEA 2180 BR IV
intervention type: Drug
intervention name: Placebo
description: Intravenous infusion
arm group label: Placebo
intervention type: Drug
intervention name: BEA 2180 BR solution for inhalation
arm group label: BEA 2180 BR inhalation
intervention type: Device
intervention name: Respimat®
arm group label: BEA 2180 BR inhalation
criteria: 
gender: Male
minimum age: 21 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Pharmaceutical Solutions