<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/NCT02194777</url>
  </required_header>
  <id_info>
    <org_study_id>1149.37</org_study_id>
    <nct_id>NCT02194777</nct_id>
  </id_info>
  <brief_title>Safety, Tolerability and Pharmacokinetics of Inhalative Administration of BIBN 4096 BS in Healthy Male and Female Volunteers</brief_title>
  <official_title>A Double-blind (at Each Dose Level), Randomised, Placebo-controlled Single Increasing Dose Safety, Tolerability and Pharmacokinetics Study in Healthy Male and Female Volunteers After Inhalative Administration of BIBN 4096 BS (Dosage: 5 - 80 mg)</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 objective of the present study is to obtain information about the safety, tolerability&#xD;
      and pharmacokinetics of BIBN 4096 BS after single inhalative administration of increasing&#xD;
      doses in healthy male and female volunteers&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2001</start_date>
  <primary_completion_date type="Actual">August 2001</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 24 days</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>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 measurement airway resistance (Raw)</measure>
    <time_frame>up to 5 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with clinically relevant changes in Blood Pressure</measure>
    <time_frame>up to 24 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with clinically relevant changes in Pulse Rate</measure>
    <time_frame>up to 24 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with clinically relevant changes in Electrocardiogram</measure>
    <time_frame>up to 24 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with clinically relevant changes in standard laboratory evaluation</measure>
    <time_frame>up to 24 days</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>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>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-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>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>MRTtot (Total mean residence time of the analyte molecules in the body)</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>
  <secondary_outcome>
    <measure>CLR (Renal clearance of the analyte in plasma)</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ae (Amount of parent drug excreted into urine)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>BIBN 4096 BS - in single rising doses</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>BIBN 4096 BS - in single rising doses</intervention_name>
    <arm_group_label>BIBN 4096 BS - in single rising doses</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants should be healthy males and females&#xD;
&#xD;
          -  Age range from 21 to 50 years&#xD;
&#xD;
          -  (Broca-Index): within +-20% of their normal weight&#xD;
&#xD;
          -  In accordance with Good Clinical Practice (GCP) and local legislation all volunteers&#xD;
             are supposed to give their written informed consent prior to admission to the study&#xD;
&#xD;
          -  As part of the screening (within 14 days before drug administration), each subject was&#xD;
             to receive a complete medical examination (including blood pressure, pulse rate,&#xD;
             medical history, documentation of demographics, inclusion/exclusion criteria and&#xD;
             concomitant therapy) as well as a 12-lead Electrocardiogram (ECG) and a lung function&#xD;
             test (Raw, SGaw). Moreover laboratory parameters (including drug screening,&#xD;
             HBs-antigen (HBs-Ag), anti HBc-antibodies, anti HCV- antibodies and Human&#xD;
             immunodeficiency virus (HIV) test as well as pregnancy test for female subjects are to&#xD;
             be determined&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any finding of the medical examination (including blood pressure, pulse rate and ECG)&#xD;
             deviating from normal and of clinical relevance&#xD;
&#xD;
          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological or hormonal disorders&#xD;
&#xD;
          -  Diseases of the central nervous system (such as epilepsy) or with psychiatric&#xD;
             disorders or neurological disorders&#xD;
&#xD;
          -  History of orthostatic hypotension, fainting spells or blackouts&#xD;
&#xD;
          -  Chronic or relevant acute infections&#xD;
&#xD;
          -  History of allergy/hypersensitivity (including drug allergy) which is deemed relevant&#xD;
             to the trial as judged by the investigator&#xD;
&#xD;
          -  Intake of a drug with a long half-life (&gt; 24 hours) within at least 1 month or less&#xD;
             than ten half-lives of the respective drug before enrolment in the study (except&#xD;
             substitution therapy regarding thyroid gland/or ovaries)&#xD;
&#xD;
          -  Use of any drugs which might influence the results of the trial within 1 week prior to&#xD;
             administration or during the trial&#xD;
&#xD;
          -  Participation in another study with an investigational drug within two months prior to&#xD;
             administration or during the trial&#xD;
&#xD;
          -  Smoker (&gt; 10 cigarettes or &gt; 3 cigars or &gt; 3 pipes/day)&#xD;
&#xD;
          -  Inability to refrain from smoking on study days&#xD;
&#xD;
          -  Alcohol abuse (&gt; 60g/day)&#xD;
&#xD;
          -  Drug abuse&#xD;
&#xD;
          -  Blood donation (&gt;= 100 ml) within four weeks prior to administration or during the&#xD;
             trial&#xD;
&#xD;
          -  Excessive physical activities within the last week before the study&#xD;
&#xD;
          -  Any laboratory value outside the reference range 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 device&#xD;
             (IUD)&#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 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <last_update_submitted>July 22, 2014</last_update_submitted>
  <last_update_submitted_qc>July 22, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 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>Olcegepant</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/NCT02194777
org study id: 1149.37
nct id: NCT02194777
lead sponsor: 
The objective of the present study is to obtain information about the safety, tolerability
      and pharmacokinetics of BIBN 4096 BS after single inhalative administration of increasing
      doses in healthy male and female volunteers
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Double
measure: Number of patients with adverse events
time frame: up to 24 days
measure: Change in lung function measurement specific conductance (SGaw)
time frame: up to 5 hours after drug administration
measure: Assessment of tolerability on a 4-point scale
time frame: 8 days after drug administration
measure: Change in lung function measurement airway resistance (Raw)
time frame: up to 5 hours after drug administration
measure: Number of patients with clinically relevant changes in Blood Pressure
time frame: up to 24 days
measure: Number of patients with clinically relevant changes in Pulse Rate
time frame: up to 24 days
measure: Number of patients with clinically relevant changes in Electrocardiogram
time frame: up to 24 days
measure: Number of patients with clinically relevant changes in standard laboratory evaluation
time frame: up to 24 days
measure: Cmax (Maximum measured 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: tmax (Time from dosing to the maximum concentration of the analyte in plasma)
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: CL/F (Apparent clearance of the analyte in plasma following extravascular administration)
time frame: up to 48 hours after drug administration
measure: MRTtot (Total mean residence time of the analyte molecules in the body)
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
measure: CLR (Renal clearance of the analyte in plasma)
time frame: up to 48 hours after drug administration
measure: Ae (Amount of parent drug excreted into urine)
time frame: up to 24 hours after drug administration
arm group label: BIBN 4096 BS - in single rising doses
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: BIBN 4096 BS - in single rising doses
arm group label: BIBN 4096 BS - in single rising doses
intervention type: Drug
intervention name: Placebo
arm group label: 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: Olcegepant