<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/NCT02194348</url>
  </required_header>
  <id_info>
    <org_study_id>1149.31</org_study_id>
    <nct_id>NCT02194348</nct_id>
  </id_info>
  <brief_title>Study to Determine Tolerability of Single Increasing Dose of BIBN 4096 BS in Healthy Male and Female Volunteers</brief_title>
  <official_title>A Double-blind (Within Dose Groups), Randomized, Placebo-controlled Single Increasing Dose Tolerability Study (Parallel Groups) in Healthy Male and Female Volunteers After Subcutaneous Administration of BIBN 4096 (Dosage: 2.5 - 30 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 was to obtain information about safety, tolerability and&#xD;
      pharmacokinetics of BIBN 4096 BS after single subcutaneous administration of increasing doses&#xD;
      in healthy male and female volunteers&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2000</start_date>
  <primary_completion_date type="Actual">March 2000</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 patients with clinically significant changes in vital signs (blood pressure, pulse rate)</measure>
    <time_frame>up to 8 days after treatment day</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with clinically significant changes in 12-lead Electrocardiogram (ECG)</measure>
    <time_frame>up to 8 days after treatment day</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with abnormal changes in laboratory parameters</measure>
    <time_frame>up to 8 days after treatment day</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>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>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>Ae (Amount of drug excreted into urine)</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>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>MRT (Mean time of residence of drug 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>CL(R) (Renal clearance of the analyte in plasma)</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</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;
          -  All female volunteers must use a safe contraception (i.e. oral contraception, spiral,&#xD;
             sterilized)&#xD;
&#xD;
          -  All female volunteers must have a negative pregnancy test&#xD;
&#xD;
          -  Prior to admission to the treatment after giving his/her informed consent (in&#xD;
             accordance with Good Clinical Practice (GCP) and local legislation) in writing each&#xD;
             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;
             ECG within 14 days before the administration of the test substance. Hematopoietic,&#xD;
             hepatic and renal function test will be carried out in the laboratory. The subjects&#xD;
             will fast for 12 hours before collection of specimens for all laboratory evaluations&#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 ten half-lives of the&#xD;
             respective drug before enrolment in the study or during the study&#xD;
&#xD;
          -  Use of any drugs which might influence the results of the trial within two weeks prior&#xD;
             to 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 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 four weeks prior to administration or during the&#xD;
             trial&#xD;
&#xD;
          -  Excessive physical activities within five days prior to administration or during the&#xD;
             trial&#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&#xD;
             pessary (IUP)&#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/NCT02194348
org study id: 1149.31
nct id: NCT02194348
lead sponsor: 
The objective of the present study was to obtain information about safety, tolerability and
      pharmacokinetics of BIBN 4096 BS after single subcutaneous administration of increasing doses
      in healthy male and female volunteers
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Number of patients with clinically significant changes in vital signs (blood pressure, pulse rate)
time frame: up to 8 days after treatment day
measure: Number of patients with clinically significant changes in 12-lead Electrocardiogram (ECG)
time frame: up to 8 days after treatment day
measure: Number of patients with abnormal changes in laboratory parameters
time frame: up to 8 days after treatment day
measure: Number of patients with adverse events
time frame: up to 24 days
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: Cmax (Maximum measured concentration of the analyte in plasma)
time frame: up to 48 hours after drug administration
measure: Ae (Amount of drug excreted into urine)
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: 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: MRT (Mean time of residence of drug 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: CL(R) (Renal clearance of the analyte in plasma)
time frame: up to 48 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