<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/NCT02211157</url>
  </required_header>
  <id_info>
    <org_study_id>1175.3</org_study_id>
    <nct_id>NCT02211157</nct_id>
  </id_info>
  <brief_title>Safety, Pharmacokinetics and Pharmacodynamics of BIRB 796 BS Tablets Administered to Healthy Human Subjects</brief_title>
  <official_title>Safety, Pharmacokinetics and Pharmacodynamics of BIRB 796 BS Tablets (20, 30, 150, 300, and 600 mg) Administered Orally to Healthy Human Subjects Once Daily for 7 Days. A Placebo Controlled, Randomised, Double Blinded 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 safety, pharmacokinetics and pharmacodynamics of BIRB 796 BS in escalating&#xD;
      multiple doses with and without a 64 g fat breakfast at the 50 mg dose level&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2000</start_date>
  <primary_completion_date type="Actual">July 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 relevant changes in laboratory parameters</measure>
    <time_frame>up to day 16</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with abnormal findings in electrocardiogram (ECG)</measure>
    <time_frame>up to day 16</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 30 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of tolerability on a 4-point scale</measure>
    <time_frame>day 16</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with clinically relevant changes in vital signs</measure>
    <time_frame>up to 16 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum plasma concentration (Cmax) for several time points</measure>
    <time_frame>up to day 9</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration-time curve (AUC) for several time points</measure>
    <time_frame>up to day 9</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to maximum concentration (tmax)</measure>
    <time_frame>up to day 9</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Elimination rate constant (λz)</measure>
    <time_frame>up to day 9</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal half-life (t1/2)</measure>
    <time_frame>up to day 9</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean residence time (MRT)</measure>
    <time_frame>up to day 9</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent clearance (CL/f)</measure>
    <time_frame>up to day 9</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent volume of distribution (Vz/F)</measure>
    <time_frame>up to day 9</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of neutrophil and monocyte activation by ex vivo stimulation of whole blood with formyl-methionyl-leucyl-phenylalanine (fMLP)</measure>
    <time_frame>up to day 9</time_frame>
    <description>Change in the Mac-1 / L-selectin ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of neutrophil and monocyte activation by ex vivo stimulation of whole blood with tumour necrosis factor (TNF) α</measure>
    <time_frame>up to day 9</time_frame>
    <description>Change in the Mac-1 / L-selectin ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of TNFα production by ex vivo stimulation of whole blood with endotoxin</measure>
    <time_frame>up to day 9</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in cellular immune response measured by Multitest®</measure>
    <time_frame>Day 8</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>BIBR 796 BS, fasted</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>dose escalation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BIBR 796 BS, fed</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>50 mg BIRB 796 BS (food effect)</description>
  </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>BIBR 796 BS</intervention_name>
    <arm_group_label>BIBR 796 BS, fasted</arm_group_label>
    <arm_group_label>BIBR 796 BS, fed</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>high fat breakfast</intervention_name>
    <arm_group_label>BIBR 796 BS, fed</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 ≥ 18 and ≤ 45 years&#xD;
&#xD;
          -  Broca ≥ - 20% and ≤ + 20%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any findings 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, immunologic,&#xD;
             hormonal disorders&#xD;
&#xD;
          -  Surgery of gastrointestinal tract (except appendectomy)&#xD;
&#xD;
          -  History of orthostatic hypotension, fainting spells and blackouts&#xD;
&#xD;
          -  Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or&#xD;
             neurological disorders&#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 drugs with a long half-life (&gt;24 hours) within 1 month prior to&#xD;
             administration or during the trial)&#xD;
&#xD;
          -  Use of any drugs which might influence the results of the trial within 10 days prior&#xD;
             to administration or during trial&#xD;
&#xD;
          -  Participation in another trial with an investigational drug within 2 months prior to&#xD;
             administration or during 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; 60 g/day)&#xD;
&#xD;
          -  Drug abuse&#xD;
&#xD;
          -  Blood donation &gt; 400 ml within 1 month prior to administration or during the trial&#xD;
&#xD;
          -  Excessive physical activities within 5 days prior to administration or during the&#xD;
             trial&#xD;
&#xD;
          -  Any laboratory value outside the reference range of clinical relevance including, but&#xD;
             not limited to total white cell count ≥ 10 x 10**9/L, C-reactive protein ≥ 4.5 mg/L,&#xD;
             Gamma-Glutamyl Transferase ≥ 40 U/L, any hemoglobin or &gt; 15 mg/dl protein or urine&#xD;
             dipstick, abnormal Multitest® assessment of cellular immunity&#xD;
&#xD;
          -  History of any familial bleeding disorder&#xD;
&#xD;
          -  Inability to comply with dietary regimen of study centre&#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 7, 2014</study_first_posted>
  <last_update_submitted>August 7, 2014</last_update_submitted>
  <last_update_submitted_qc>August 7, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 8, 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/NCT02211157
org study id: 1175.3
nct id: NCT02211157
lead sponsor: 
Study to assess safety, pharmacokinetics and pharmacodynamics of BIRB 796 BS in escalating
      multiple doses with and without a 64 g fat breakfast at the 50 mg dose level
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Number of patients with clinically relevant changes in laboratory parameters
time frame: up to day 16
measure: Number of patients with abnormal findings in electrocardiogram (ECG)
time frame: up to day 16
measure: Number of patients with adverse events
time frame: up to 30 days
measure: Assessment of tolerability on a 4-point scale
time frame: day 16
measure: Number of patients with clinically relevant changes in vital signs
time frame: up to 16 days
measure: Maximum plasma concentration (Cmax) for several time points
time frame: up to day 9
measure: Area under the plasma concentration-time curve (AUC) for several time points
time frame: up to day 9
measure: Time to maximum concentration (tmax)
time frame: up to day 9
measure: Elimination rate constant (λz)
time frame: up to day 9
measure: Terminal half-life (t1/2)
time frame: up to day 9
measure: Mean residence time (MRT)
time frame: up to day 9
measure: Apparent clearance (CL/f)
time frame: up to day 9
measure: Apparent volume of distribution (Vz/F)
time frame: up to day 9
measure: Assessment of neutrophil and monocyte activation by ex vivo stimulation of whole blood with formyl-methionyl-leucyl-phenylalanine (fMLP)
time frame: up to day 9
description: Change in the Mac-1 / L-selectin ratio
measure: Assessment of neutrophil and monocyte activation by ex vivo stimulation of whole blood with tumour necrosis factor (TNF) α
time frame: up to day 9
description: Change in the Mac-1 / L-selectin ratio
measure: Assessment of TNFα production by ex vivo stimulation of whole blood with endotoxin
time frame: up to day 9
measure: Changes in cellular immune response measured by Multitest®
time frame: Day 8
arm group label: BIBR 796 BS, fasted
arm group type: Experimental
description: dose escalation
arm group label: BIBR 796 BS, fed
arm group type: Experimental
description: 50 mg BIRB 796 BS (food effect)
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: BIBR 796 BS
arm group label: BIBR 796 BS, fasted
arm group label: BIBR 796 BS, fed
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
intervention type: Other
intervention name: high fat breakfast
arm group label: BIBR 796 BS, fed
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