<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/NCT02199860</url>
  </required_header>
  <id_info>
    <org_study_id>1149.44</org_study_id>
    <nct_id>NCT02199860</nct_id>
  </id_info>
  <brief_title>Single Rising Dose Study Investigating the Safety, Tolerability and Pharmacokinetics of Spray Dried BIBN 4096 BS After Inhalation Administration in Healthy Male and Female Volunteers</brief_title>
  <official_title>A Double-blind (at Each Dose Level), Randomised, Placebo-controlled, Single Rising Dose Study Investigating the Safety, Tolerability and Pharmacokinetics of Two Spray-dried Formulations of BIBN 4096 BS After Inhalation Administration in Healthy Male and Female Volunteers</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 purpose of the present study was to obtain information about the safety, tolerability and&#xD;
      pharmacokinetics of BIBN 4096 BS after single inhalation administration of rising doses of&#xD;
      spray-dried powder in healthy male and female volunteers. According to the original protocol,&#xD;
      the primary objective was to investigate the safety and tolerability of single doses of a new&#xD;
      spray-dried inhalation formulation of BIBN 4096 BS (SD I). Following implementation of&#xD;
      Amendment 2, this objective was extended to the second spray-dried inhalation formulation SD&#xD;
      II with and without concomitant administration of lactose&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2003</start_date>
  <primary_completion_date type="Actual">February 2004</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>Number of patients with adverse events</measure>
    <time_frame>up to 25 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of tolerability on a 4-point scale</measure>
    <time_frame>8 days after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in lung function measurements airway resistance (Raw)</measure>
    <time_frame>up to 5 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in lung function measurement specific conductance (SGaw)</measure>
    <time_frame>up to 5 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in lunf function measurement forced expiratory volume in 1 second (FEV1)</measure>
    <time_frame>up to 5 hours after drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cmax (Maximum measured concentration of the analyte in plasma)</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tmax (Time from dosing to the maximum concentration of the analyte in plasma)</measure>
    <time_frame>up to 48 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 48 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 last quantifiable data point)</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>λz (Terminal rate constant in plasma)</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t½ (Terminal half-life of the analyte in plasma)</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRTih (Mean residence time of the analyte in the body after inhalation)</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL/F (Apparent clearance of the analyte in plasma following extravascular administration)</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vz/F (Apparent volume of distribution of the analyte during the terminal phase)</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">63</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>SD I - single rising doses</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>SD II - single rising doses</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>SD II - single rising doses + Placebo</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>SD I</intervention_name>
    <arm_group_label>SD I - single rising doses</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SD II</intervention_name>
    <arm_group_label>SD II - single rising doses</arm_group_label>
    <arm_group_label>SD II - single rising doses + Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>SD II - single rising doses + Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Subjects could be included in the study if they met the following criteria:&#xD;
&#xD;
          -  Healthy male or female volunteers&#xD;
&#xD;
          -  Written informed consent in accordance with Good Clinical Practice (GCP) and the local&#xD;
             legislation prior to admission to the study&#xD;
&#xD;
          -  Age 21 - 50 years&#xD;
&#xD;
          -  Body mass index (BMI): 18.5 - 29.9 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subjects were not allowed to participate if any of the following applied:&#xD;
&#xD;
          -  Any finding of the medical examination (including blood pressure, pulse rate,&#xD;
             Respiratory rate, body temperature and ECG) deviating from normal and of clinical&#xD;
             relevance&#xD;
&#xD;
          -  Raw &gt; 3 cm H2O • s • L-1 or FEV1 &lt;80% of predicted&#xD;
&#xD;
          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological or hormonal disorders&#xD;
&#xD;
          -  Diseases of the central nervous system, psychiatric disorders or neurological&#xD;
             disorders&#xD;
&#xD;
          -  History of relevant orthostatic hypotension, fainting spells or blackouts,&#xD;
&#xD;
          -  Chronic or relevant acute infections&#xD;
&#xD;
          -  History of allergy/hypersensitivity (including drug allergy) which was deemed relevant&#xD;
             to the trial as judged by the investigator&#xD;
&#xD;
          -  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 before enrolment in the study&#xD;
&#xD;
          -  Use of any drugs which might influence the results of the trial (within 1 week prior&#xD;
             to administration of investigational drug or during the trial)&#xD;
&#xD;
          -  Participation in another trial with an investigational drug (within 2 months prior to&#xD;
             drug administration or during the trial)&#xD;
&#xD;
          -  Smoker (&gt;10 cigarettes/day or &gt;3 cigars/day or &gt;3 pipes/day)&#xD;
&#xD;
          -  Inability to refrain from smoking on trial days&#xD;
&#xD;
          -  Alcohol abuse (&gt;60 gram/day)&#xD;
&#xD;
          -  Drug abuse&#xD;
&#xD;
          -  Blood donation (≥100 mL within 4 weeks prior to administration of investigational drug&#xD;
             or during the trial)&#xD;
&#xD;
          -  Excessive physical activities (within the last week before the study)&#xD;
&#xD;
          -  Any laboratory value outside the reference range and of clinical relevance&#xD;
&#xD;
          -  For female subjects:&#xD;
&#xD;
               -  Pregnancy&#xD;
&#xD;
               -  Positive pregnancy test&#xD;
&#xD;
               -  No adequate contraception e.g. oral contraceptives, sterilization, intrauterine&#xD;
                  device&#xD;
&#xD;
               -  Inability to maintain this adequate contraception during the whole study period,&#xD;
&#xD;
               -  Lactation period&#xD;
      </textblock>
    </criteria>
    <gender>All</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>July 2014</verification_date>
  <study_first_submitted>July 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>July 24, 2014</last_update_submitted>
  <last_update_submitted_qc>July 24, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 25, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Aspiration</mesh_term>
  </condition_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/NCT02199860
org study id: 1149.44
nct id: NCT02199860
lead sponsor: 
The purpose of the present study was to obtain information about the safety, tolerability and
      pharmacokinetics of BIBN 4096 BS after single inhalation administration of rising doses of
      spray-dried powder in healthy male and female volunteers. According to the original protocol,
      the primary objective was to investigate the safety and tolerability of single doses of a new
      spray-dried inhalation formulation of BIBN 4096 BS (SD I). Following implementation of
      Amendment 2, this objective was extended to the second spray-dried inhalation formulation SD
      II with and without concomitant administration of lactose
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Double
measure: Number of patients with adverse events
time frame: up to 25 days
measure: Assessment of tolerability on a 4-point scale
time frame: 8 days after drug administration
measure: Change in lung function measurements airway resistance (Raw)
time frame: up to 5 hours after drug administration
measure: Change in lung function measurement specific conductance (SGaw)
time frame: up to 5 hours after drug administration
measure: Change in lunf function measurement forced expiratory volume in 1 second (FEV1)
time frame: up to 5 hours after drug administration
measure: Cmax (Maximum measured concentration of the analyte in plasma)
time frame: up to 48 hours after drug administration
measure: tmax (Time from dosing to the maximum concentration of the analyte in plasma)
time frame: up to 48 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 48 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 last quantifiable data point)
time frame: up to 48 hours after drug administration
measure: λz (Terminal rate constant in plasma)
time frame: up to 48 hours after drug administration
measure: t½ (Terminal half-life of the analyte in plasma)
time frame: up to 48 hours after drug administration
measure: MRTih (Mean residence time of the analyte in the body after inhalation)
time frame: up to 48 hours after drug administration
measure: CL/F (Apparent clearance of the analyte in plasma following extravascular administration)
time frame: up to 48 hours after drug administration
measure: Vz/F (Apparent volume of distribution of the analyte during the terminal phase)
time frame: up to 48 hours after drug administration
arm group label: SD I - single rising doses
arm group type: Experimental
arm group label: SD II - single rising doses
arm group type: Experimental
arm group label: SD II - single rising doses + Placebo
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: SD I
arm group label: SD I - single rising doses
intervention type: Drug
intervention name: SD II
arm group label: SD II - single rising doses
arm group label: SD II - single rising doses + Placebo
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
arm group label: SD II - single rising doses + Placebo
criteria: 
gender: All
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: Respiratory Aspiration