<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/NCT02198326</url>
  </required_header>
  <id_info>
    <org_study_id>1149.3</org_study_id>
    <nct_id>NCT02198326</nct_id>
  </id_info>
  <brief_title>Single Rising Dose Tolerability Study of BIBN 4096 BS in Healthy Male and Female Volunteers</brief_title>
  <official_title>A Double-blind (Within Dose Groups), Placebo-controlled Single Rising Dose Tolerability Study (Parallel Groups) in Healthy Male and Female Volunteers After Intranasal Administration of BIBN 4096 BS (Dosage: 2.5 - 20 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 intranasal administration of increasing&#xD;
      doses in healthy male and female volunteers&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 1999</start_date>
  <primary_completion_date type="Actual">August 1999</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>Changes in nasal mucosa assessed by rhinoscopy</measure>
    <time_frame>up to 2 hours after treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in nasal flow and resistance assessed by rhinomanometry</measure>
    <time_frame>up to 2 hours after treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 24 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>AUC (Area under the concentration-time curve of the analyte in plasma)</measure>
    <time_frame>up to 12 hours after intranasal administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax (Maximum measured concentration of the analyte in plasma)</measure>
    <time_frame>up to 12 hours after intranasal 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 12 hours after intranasal administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRT (Mean residence time of the analyte in the body)</measure>
    <time_frame>up to 12 hours after intranasal administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t½ (Terminal half-life of the analyte in plasma)</measure>
    <time_frame>up to 12 hours after intranasal administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL (systemic clearance)</measure>
    <time_frame>up to 12 hours after intranasal administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vd (Volume of distribution)</measure>
    <time_frame>up to 12 hours after intranasal administration</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</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;
          -  Within +- 20% of their normal weight (Broca-Index)&#xD;
&#xD;
          -  All female volunteers must use a safe contraception (i.e. oral contraceptive, spiral;&#xD;
             sterilized) and must have a negative pregnancy test&#xD;
&#xD;
          -  In accordance with Good Clinical Practice (GCP) and local legislation each volunteer&#xD;
             is supposed to give his written informed consent prior to admission to the study&#xD;
&#xD;
          -  Each subject will have his medical history taken and will receive a complete medical&#xD;
             examination (incl. blood pressure and pulse rate measurements) as well as a 12-lead&#xD;
             Electrocardiogram (ECG) within 14 days before the first administration of the test&#xD;
             substance&#xD;
&#xD;
          -  Haematopoietic, hepatic and renal function test will be carried out in the laboratory&#xD;
&#xD;
          -  The subjects will fast for 12 hours before collection of specimens for all laboratory&#xD;
             evaluations&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Volunteers will be excluded from the study if the results of the medical examination&#xD;
             or laboratory tests (especially those which indicate liver malfunction) are judged by&#xD;
             the clinical investigator to differ significantly from normal clinical values&#xD;
&#xD;
          -  Volunteers with known gastrointestinal, hepatic, renal, respiratory, cardiovascular,&#xD;
             metabolic, immunological or hormonal disorders&#xD;
&#xD;
          -  Volunteers with diseases of the central nervous system (such as epilepsy) or with&#xD;
             psychiatric disorders&#xD;
&#xD;
          -  History of orthostatic hypotension, fainting spells or blackouts&#xD;
&#xD;
          -  Chronic or relevant acute infections (especially common cold with rhinitis)&#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 ten half-lives of the&#xD;
             respective drug before enrolment in the study&#xD;
&#xD;
          -  Use of any other drugs which might influence the results of the trial during the week&#xD;
             previous to the start of the study&#xD;
&#xD;
          -  Participation in another study with an investigational drug within the last two months&#xD;
             preceding this study&#xD;
&#xD;
          -  Smoker (&gt; 10 cigarettes or 3 cigars or 3 pipes/day)&#xD;
&#xD;
          -  Inability to refrain from smoking on study days&#xD;
&#xD;
          -  Alcohol abuse (&gt; 40g/day)&#xD;
&#xD;
          -  Drug abuse&#xD;
&#xD;
          -  Blood donation ( &gt;= 100 ml) within the last 4 weeks&#xD;
&#xD;
          -  Excessive physical activities (e.g. competitive sports) within the last week before&#xD;
             the study&#xD;
&#xD;
          -  Pregnant and/or lactating volunteers&#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 22, 2014</study_first_submitted>
  <study_first_submitted_qc>July 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 23, 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/NCT02198326
org study id: 1149.3
nct id: NCT02198326
lead sponsor: 
The objective of the present study is to obtain information about the safety, tolerability
      and pharmacokinetics of BIBN 4096 BS after single intranasal administration of increasing
      doses in healthy male and female volunteers
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Changes in nasal mucosa assessed by rhinoscopy
time frame: up to 2 hours after treatment
measure: Changes in nasal flow and resistance assessed by rhinomanometry
time frame: up to 2 hours after treatment
measure: Number of patients with adverse events
time frame: up to 24 days
measure: AUC (Area under the concentration-time curve of the analyte in plasma)
time frame: up to 12 hours after intranasal administration
measure: Cmax (Maximum measured concentration of the analyte in plasma)
time frame: up to 12 hours after intranasal administration
measure: tmax (Time from dosing to the maximum concentration of the analyte in plasma)
time frame: up to 12 hours after intranasal administration
measure: MRT (Mean residence time of the analyte in the body)
time frame: up to 12 hours after intranasal administration
measure: t½ (Terminal half-life of the analyte in plasma)
time frame: up to 12 hours after intranasal administration
measure: CL (systemic clearance)
time frame: up to 12 hours after intranasal administration
measure: Vd (Volume of distribution)
time frame: up to 12 hours after intranasal 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