<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/NCT02209805</url>
  </required_header>
  <id_info>
    <org_study_id>1175.14</org_study_id>
    <nct_id>NCT02209805</nct_id>
  </id_info>
  <brief_title>Safety and Pharmacokinetics of BIRB 796 BS Tablets Administered to Healthy Human Subjects</brief_title>
  <official_title>Safety and Pharmacokinetics of BIRB 796 BS Tablets Administered Twice Daily Orally (Total Daily Dose 30, 60, and 120 mg) to Healthy Human Subjects for 14 Days. A Double-blind, Placebo-controlled, Parallel Group Study.</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 safety and pharmacokinetics of BIRB 796 BS tablets administered as&#xD;
      multiple daily doses at various dose levels.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2001</start_date>
  <primary_completion_date type="Actual">March 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>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</measure>
    <time_frame>up to 21 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with clinically significant changes in laboratory parameters</measure>
    <time_frame>up to 21 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with abnormal findings in electrocardiogram</measure>
    <time_frame>up to 21 days</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>Maximum concentration of the analyte in plasma (Cmax) for several time points</measure>
    <time_frame>up to 36 hours after dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration versus time curve (AUC) for several time points</measure>
    <time_frame>up to 36 hours after dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time at which maximum plasma concentration occurred over a dosing interval (tmax)</measure>
    <time_frame>up to 36 hours after dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal elimination rate constant (λZ)</measure>
    <time_frame>up to 36 hours after dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Elimination half-life (t1/2)</measure>
    <time_frame>up to 36 hours after dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean residence time (MRT)</measure>
    <time_frame>up to 36 hours after dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent oral clearance (CL/F)</measure>
    <time_frame>up to 36 hours after dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent volume of distribution during the terminal elimination phase, divided by F (bioavailability factor) (Vz/F)</measure>
    <time_frame>up to 36 hours after dosing</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">49</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>BIRB 796 BS, low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>BIRB 796 BS, high 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>
  <arm_group>
    <arm_group_label>BIRB 796 BS, medium dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BIRB 796 BS, low dose</intervention_name>
    <arm_group_label>BIRB 796 BS, low dose</arm_group_label>
    <arm_group_label>BIRB 796 BS, medium dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BIRB 796 BS, high dose</intervention_name>
    <arm_group_label>BIRB 796 BS, high dose</arm_group_label>
    <arm_group_label>BIRB 796 BS, medium 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 and local&#xD;
             legislation&#xD;
&#xD;
          -  Age &gt;= 18 and &lt;= 45 years&#xD;
&#xD;
          -  Broca &gt;= - 20 % and &lt;= + 20%&#xD;
&#xD;
          -  Able to communicate well with the investigator and to comply with study requirements&#xD;
&#xD;
          -  &gt; 10 elimination half lives present since last use of any investigational drug for&#xD;
             that investigational drug&#xD;
&#xD;
          -  Laboratory values within a clinically relevant reference range&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any finding of the medical examination (including blood pressure, pulse rate,&#xD;
             temperature, and EKG) deviating from normal and of clinical relevance&#xD;
&#xD;
          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological 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;
          -  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;
          -  History of vasculitis (past history of fever, malaise, myalgias, rash, etc.)&#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; 1 months prior to&#xD;
             administration or during trial)&#xD;
&#xD;
          -  Smoker&#xD;
&#xD;
          -  Inability to refrain from smoking on trial days&#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.) &lt; one week prior to administration of study drug&#xD;
&#xD;
          -  Blood donation or loss &gt; 400 mL (&lt; 1 month prior to administration or during the&#xD;
             trial)&#xD;
&#xD;
          -  Excessive physical activities (&lt; 5 days prior to administration or during the trial)&#xD;
&#xD;
          -  Following specific laboratory findings: total white blood cell &gt;= 10 x 109/L,&#xD;
             C-Reactive Protein &gt;= 4.5 mg/L, gamma-glutamyl-transferase &gt;= 25 U/L, aspartate&#xD;
             transaminase &gt;= 16 U/L, alanine transaminase &gt;= 20 U/L any erythrocytes or &gt; 15 mg/dl&#xD;
             protein on urine dipstick&#xD;
&#xD;
          -  Any EKG value outside of the reference range of clinical relevance including, but not&#xD;
             limited to QTcB &gt; 480 ms, PR interval &gt; 240 ms, QRS interval &gt; 110 ms&#xD;
&#xD;
          -  History of any familial bleeding disorder&#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>45 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>August 2014</verification_date>
  <study_first_submitted>August 5, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <last_update_submitted>August 5, 2014</last_update_submitted>
  <last_update_submitted_qc>August 5, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 6, 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/NCT02209805
org study id: 1175.14
nct id: NCT02209805
lead sponsor: 
Study to assess the safety and pharmacokinetics of BIRB 796 BS tablets administered as
      multiple daily doses at various dose levels.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Number of patients with clinically significant changes in vital signs
time frame: up to 21 days
measure: Number of patients with clinically significant changes in laboratory parameters
time frame: up to 21 days
measure: Number of patients with abnormal findings in electrocardiogram
time frame: up to 21 days
measure: Number of patients with adverse events
time frame: up to 24 days
measure: Maximum concentration of the analyte in plasma (Cmax) for several time points
time frame: up to 36 hours after dosing
measure: Area under the plasma concentration versus time curve (AUC) for several time points
time frame: up to 36 hours after dosing
measure: Time at which maximum plasma concentration occurred over a dosing interval (tmax)
time frame: up to 36 hours after dosing
measure: Terminal elimination rate constant (λZ)
time frame: up to 36 hours after dosing
measure: Elimination half-life (t1/2)
time frame: up to 36 hours after dosing
measure: Mean residence time (MRT)
time frame: up to 36 hours after dosing
measure: Apparent oral clearance (CL/F)
time frame: up to 36 hours after dosing
measure: Apparent volume of distribution during the terminal elimination phase, divided by F (bioavailability factor) (Vz/F)
time frame: up to 36 hours after dosing
arm group label: BIRB 796 BS, low dose
arm group type: Experimental
arm group label: BIRB 796 BS, high dose
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
arm group label: BIRB 796 BS, medium dose
arm group type: Experimental
intervention type: Drug
intervention name: BIRB 796 BS, low dose
arm group label: BIRB 796 BS, low dose
arm group label: BIRB 796 BS, medium dose
intervention type: Drug
intervention name: BIRB 796 BS, high dose
arm group label: BIRB 796 BS, high dose
arm group label: BIRB 796 BS, medium dose
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor