<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/NCT02198352</url>
  </required_header>
  <id_info>
    <org_study_id>1149.1</org_study_id>
    <nct_id>NCT02198352</nct_id>
  </id_info>
  <brief_title>Study to Determine Tolerability After Intravenous Administration of BIBN 4096 BS in Healthy Male and Female Volunteers</brief_title>
  <official_title>A Double-blind, Placebo-controlled Single Rising Dose Tolerability Study (Parallel Groups) in Healthy Male and Female Volunteers After Intravenous Administration of BIBN 4096 BS (Dosage: 0.1 - 10 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 intravenous administration of increasing&#xD;
      doses in healthy male and female volunteers&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 1998</start_date>
  <primary_completion_date type="Actual">August 1998</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 adverse events</measure>
    <time_frame>up to 2 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with clinically significant changes in vital signs (blood pressure, pulse rate, respiratory rate)</measure>
    <time_frame>up to 8 days after last study day</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with abnormal changes in laboratory parameters</measure>
    <time_frame>up to 8 days after last study day</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with clinically relevant changes in venous-occlusion plethysmography</measure>
    <time_frame>up to 8 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with clinically significant changes in ECG (Electrocardiogram)</measure>
    <time_frame>up to 8 days after last study day</time_frame>
  </primary_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 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax (Maximum measured concentration of the analyte in plasma)</measure>
    <time_frame>up to 24 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 24 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 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL (Total clearance of the analyte in plasma following extravascular administration)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vz (Apparent volume of distribution during the terminal elimination phase)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vss (Volume of distribution at steady state)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of urinary excretion of BIBN 4096 BS</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">55</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 volunteers&#xD;
             are supposed to give their 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&#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 28, 2014</last_update_submitted>
  <last_update_submitted_qc>July 28, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 29, 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/NCT02198352
org study id: 1149.1
nct id: NCT02198352
lead sponsor: 
The objective of the present study is to obtain information about the safety, tolerability
      and pharmacokinetics of BIBN 4096 BS after single intravenous administration of increasing
      doses in healthy male and female volunteers
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Number of subjects with adverse events
time frame: up to 2 months
measure: Number of subjects with clinically significant changes in vital signs (blood pressure, pulse rate, respiratory rate)
time frame: up to 8 days after last study day
measure: Number of subjects with abnormal changes in laboratory parameters
time frame: up to 8 days after last study day
measure: Number of subjects with clinically relevant changes in venous-occlusion plethysmography
time frame: up to 8 hours after drug administration
measure: Number of subjects with clinically significant changes in ECG (Electrocardiogram)
time frame: up to 8 days after last study day
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 24 hours after drug administration
measure: Cmax (Maximum measured concentration of the analyte in plasma)
time frame: up to 24 hours after drug administration
measure: t½ (Terminal half-life of the analyte in plasma)
time frame: up to 24 hours after drug administration
measure: MRT (Mean residence time of the analyte in the body)
time frame: up to 24 hours after drug administration
measure: CL (Total clearance of the analyte in plasma following extravascular administration)
time frame: up to 24 hours after drug administration
measure: Vz (Apparent volume of distribution during the terminal elimination phase)
time frame: up to 24 hours after drug administration
measure: Vss (Volume of distribution at steady state)
time frame: up to 24 hours after drug administration
measure: Percentage of urinary excretion of BIBN 4096 BS
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