<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/NCT02254057</url>
  </required_header>
  <id_info>
    <org_study_id>1192.1</org_study_id>
    <nct_id>NCT02254057</nct_id>
  </id_info>
  <brief_title>Tolerability and Pharmacokinetics/-Dynamics of Single Rising Doses BIBT 986 BS in Healthy Male Subjects</brief_title>
  <official_title>Tolerability and Pharmacokinetics/-Dynamics of Single Rising Doses of 0.1 mg, 0.3 mg, 1.0 mg, 2.5 mg, 5.0 mg, and 10.0 mg BIBT 986 BS (IV Infusion Over 30 Minutes) in Healthy Male Subjects. Placebo Controlled, Double Blind Randomised at Each Dose Level</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Study to assess the tolerability of BIBT 986 BS after intravenous infusions of 0.1, 0.3, 1.0,&#xD;
      2.5, 5.0, and 10 mg, to assess the pharmacokinetics of BIBT 986 BS after intravenous infusion&#xD;
      and to assess the effect of BIBT 986 BS on blood coagulation parameters&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2002</start_date>
  <primary_completion_date type="Actual">October 2002</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>AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity after single dose administration)</measure>
    <time_frame>up to 48 hours after start of infusion</time_frame>
  </primary_outcome>
  <primary_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 drug plasma concentration after single dose administration)</measure>
    <time_frame>up to 48 hours after start of infusion</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>C29 (plasma concentration of BIBT 986 BS at the end of infusion)</measure>
    <time_frame>29 minutes after start of infusion</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>t1/2 (Terminal half-life of the analyte in plasma after single dose administration)</measure>
    <time_frame>up to 48 hours after start of infusion</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>CL (Total clearance of the analyte in plasma following intravascular administration)</measure>
    <time_frame>up to 48 hours after start of infusion</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Vss (Apparent volume of distribution at steady state following intravascular administration)</measure>
    <time_frame>up to 48 hours after start of infusion</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>urinary excretion of BIBT 986 BS</measure>
    <time_frame>up to 48 hours after start of infusion</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>CLR (Renal clearance of the analyte in plasma following intravascular administration)</measure>
    <time_frame>up to 48 hours after start of infusion</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>MRT (Mean residence time of drug molecules in the body after intravascular administration)</measure>
    <time_frame>up to 48 hours after start of infusion</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in activated partial thromboplastin time (aPTT)</measure>
    <time_frame>up to 48 hours after start of infusion</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in International Normalised Ratio (INR)</measure>
    <time_frame>up to 48 hours after start of infusion</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in ecarin clotting time (ECT)</measure>
    <time_frame>up to 48 hours after start of infusion</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in thrombin time (TT)</measure>
    <time_frame>up to 48 hours after start of infusion</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with clinically significant findings in vital signs</measure>
    <time_frame>up to 48 hours after start of infusion</time_frame>
    <description>pulse rate, blood pressure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with clinically significant findings in electrocardiogram</measure>
    <time_frame>up to 48 hours after start of infusion</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with clinically significant findings in laboratory tests</measure>
    <time_frame>up to 48 hours after start of infusion</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 48 hours after start of infusion</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with histamine in blood</measure>
    <time_frame>up to 48 hours after start of infusion</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">47</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>BIBT 986 BS - single rising dose</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>BIBT 986 BS - single rising dose</intervention_name>
    <arm_group_label>BIBT 986 BS - single rising dose</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;
          -  Healthy male subjects as determined by results of screening&#xD;
&#xD;
          -  Signed written informed consent in accordance with Good Clinical Practice (GCP) and&#xD;
             local legislation&#xD;
&#xD;
          -  Age &gt;= 18 and &lt;= 55 years&#xD;
&#xD;
          -  BMI &gt;= 18.5 and &lt;= 29.9 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any finding of the medical examination (including blood pressure, pulse rate, and&#xD;
             electrocardiogram) deviating from normal and of clinical relevance&#xD;
&#xD;
          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic&#xD;
             or hormonal disorders&#xD;
&#xD;
          -  Surgery of gastrointestinal tract (except appendectomy)&#xD;
&#xD;
          -  Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or&#xD;
             neurological disorders&#xD;
&#xD;
          -  Relevant history of orthostatic hypotension, fainting spells or blackouts&#xD;
&#xD;
          -  Any bleeding disorder including prolonged or habitual bleeding&#xD;
&#xD;
          -  History of other hematologic disease, cerebral bleeding (e.g. after a car accident),&#xD;
             commotio cerebri&#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;
          -  Seasonal rhinitis&#xD;
&#xD;
          -  Thrombocytes &lt; 150000/μl&#xD;
&#xD;
          -  Intake of drugs with a long half-life (&gt; 24 hours) (&lt; 1 month prior to administration&#xD;
             or during the trial)&#xD;
&#xD;
          -  Use of any drugs, which might influence the results of the trial (&lt; 10 days prior to&#xD;
             administration or during the trial)&#xD;
&#xD;
          -  Participation in another trial with an investigational drug (&lt; 2 months prior to&#xD;
             administration or during trial)&#xD;
&#xD;
          -  Smoker (&gt; 10 cigarettes or &gt;3 cigars or &gt;3 pipes/day)&#xD;
&#xD;
          -  Alcohol abuse (&gt; 60 g/day)&#xD;
&#xD;
          -  Drug abuse&#xD;
&#xD;
          -  Use of methylxanthine-containing drinks or foods (coffee, tea, cola, energy drinks,&#xD;
             chocolate, etc.), grapefruit or grapefruit juice, alcohol, green tea, or tobacco &lt; 5&#xD;
             days prior to administration of study drug or during trial&#xD;
&#xD;
          -  Blood donation or loss &gt; 400 ml, &lt; 1 month prior to administration or during the trial&#xD;
&#xD;
          -  Excessive physical activities &lt; 5 days prior to administration of study drug or during&#xD;
             trial&#xD;
&#xD;
          -  Clinically relevant laboratory abnormalities&#xD;
&#xD;
          -  Any ECG value outside of the reference range of clinical relevance including, but not&#xD;
             limited to QRS interval &gt; 110 ms or QTcB &gt; 450 ms&#xD;
&#xD;
          -  Inability to comply with dietary regimen of study centre&#xD;
&#xD;
          -  Inability to comply with investigator's instructions&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 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>September 2014</verification_date>
  <study_first_submitted>September 30, 2014</study_first_submitted>
  <study_first_submitted_qc>September 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>September 30, 2014</last_update_submitted>
  <last_update_submitted_qc>September 30, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 1, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02254057
org study id: 1192.1
nct id: NCT02254057
lead sponsor: 
Study to assess the tolerability of BIBT 986 BS after intravenous infusions of 0.1, 0.3, 1.0,
      2.5, 5.0, and 10 mg, to assess the pharmacokinetics of BIBT 986 BS after intravenous infusion
      and to assess the effect of BIBT 986 BS on blood coagulation parameters
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity after single dose administration)
time frame: up to 48 hours after start of infusion
measure: AUC0-tz (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable drug plasma concentration after single dose administration)
time frame: up to 48 hours after start of infusion
measure: C29 (plasma concentration of BIBT 986 BS at the end of infusion)
time frame: 29 minutes after start of infusion
measure: t1/2 (Terminal half-life of the analyte in plasma after single dose administration)
time frame: up to 48 hours after start of infusion
measure: CL (Total clearance of the analyte in plasma following intravascular administration)
time frame: up to 48 hours after start of infusion
measure: Vss (Apparent volume of distribution at steady state following intravascular administration)
time frame: up to 48 hours after start of infusion
measure: urinary excretion of BIBT 986 BS
time frame: up to 48 hours after start of infusion
measure: CLR (Renal clearance of the analyte in plasma following intravascular administration)
time frame: up to 48 hours after start of infusion
measure: MRT (Mean residence time of drug molecules in the body after intravascular administration)
time frame: up to 48 hours after start of infusion
measure: Change in activated partial thromboplastin time (aPTT)
time frame: up to 48 hours after start of infusion
measure: Change in International Normalised Ratio (INR)
time frame: up to 48 hours after start of infusion
measure: Change in ecarin clotting time (ECT)
time frame: up to 48 hours after start of infusion
measure: Change in thrombin time (TT)
time frame: up to 48 hours after start of infusion
measure: Number of patients with clinically significant findings in vital signs
time frame: up to 48 hours after start of infusion
description: pulse rate, blood pressure
measure: Number of patients with clinically significant findings in electrocardiogram
time frame: up to 48 hours after start of infusion
measure: Number of patients with clinically significant findings in laboratory tests
time frame: up to 48 hours after start of infusion
measure: Number of patients with adverse events
time frame: up to 48 hours after start of infusion
measure: Number of patients with histamine in blood
time frame: up to 48 hours after start of infusion
arm group label: BIBT 986 BS - single rising dose
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: BIBT 986 BS - single rising dose
arm group label: BIBT 986 BS - single rising dose
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor