<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/NCT02211144</url>
  </required_header>
  <id_info>
    <org_study_id>1175.21</org_study_id>
    <nct_id>NCT02211144</nct_id>
  </id_info>
  <brief_title>Safety and Pharmacokinetics of BIRB 796 BS Tablets Administered Twice Daily Orally to Healthy Human Subjects</brief_title>
  <official_title>Safety and Pharmacokinetics of BIRB 796 BS Tablets Administered Twice Daily Orally (Total Daily Dose 90, 120, 150 or 180 mg) to Healthy Human Subjects for 14 Days. A Placebo-controlled, Dose Escalation Study Double Blinded 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 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>March 2002</start_date>
  <primary_completion_date type="Actual">November 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>Number of patients with clinically significant changes in vital signs (pulse rate, systolic and diastolic blood pressure)</measure>
    <time_frame>up to day 21</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with clinically relevant changes in laboratory parameters</measure>
    <time_frame>up to day 21</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with clinical relevant findings in electrocardiogram (ECG)</measure>
    <time_frame>up to day 21</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 35 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical assessment of tolerability on a 4-point scale</measure>
    <time_frame>day 21</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum observed plasma concentration during steady state dosing interval (Cmax,ss)</measure>
    <time_frame>up to day 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>area under the plasma concentration versus time curve at different time points (AUC)</measure>
    <time_frame>up to day 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to the maximum plasma concentration at steady state (tmax,ss)</measure>
    <time_frame>up to day 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Elimination half-life (t1/2)</measure>
    <time_frame>up to day 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal elimination rate constant (λz)</measure>
    <time_frame>up to day 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average steady state plasma concentration (Css)</measure>
    <time_frame>up to day 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean residence time (MRT)</measure>
    <time_frame>up to day 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total apparent oral clearance of drug from plasma after oral administration (CL/F )</measure>
    <time_frame>up to day 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent volume of distribution based on terminal elimination phase, divided by F (bioavailability factor) (Vz/F)</measure>
    <time_frame>up to day 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Morning trough plasma concentration prior day 14</measure>
    <time_frame>on day 2, 3, 5, 7, 9, 13 and 14</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>BIRB 796 BS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>in escalating doses</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>BIRB 796 BS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>BIRB 796 BS</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male or female 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;
          -  Female subjects who were not lactating and not of child bearing potential as defined&#xD;
             by surgically sterile or post menopausal (no periods for at least 12 months and&#xD;
             elevated follicle stimulating hormone (FSH) with low estradiol while on no estrogen&#xD;
             supplementation). Females were to use barrier contraception (e.g. condoms) prior to&#xD;
             administration of study medication, during the study and at least one month after&#xD;
             release from the study. Women must have had negative blood pregnancy tests&#xD;
&#xD;
          -  Age ≥ 18 and ≤ 60 years&#xD;
&#xD;
          -  Body mass index (BMI) ≥ 18.5 and ≤ 29.9 kg/m2&#xD;
&#xD;
          -  Able to communicate well with the investigator and to comply with study requirements&#xD;
&#xD;
          -  Laboratory values within a clinically defined reference range&#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;
          -  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 (at least 10 times the relevant elimination half-life) or during the&#xD;
             trial)&#xD;
&#xD;
          -  Having had prescription medication 2 weeks prior to study drug administration or over&#xD;
             the counter medication 1 week prior to study drug administration (at least 10 times&#xD;
             the relevant elimination half-life)&#xD;
&#xD;
          -  Smoker&#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&#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: white blood cell count, C-reactive protein,&#xD;
             gamma-glutamyl-transferase, aspartate transaminase, alanine transaminase, or glutamate&#xD;
             dehydrogenase above the normal range; any erythrocytes or &gt; 15 mg/dl protein on urine&#xD;
             dipstick if not menstruating&#xD;
&#xD;
          -  Any EKG value outside of the reference range of clinical relevance including, but not&#xD;
             limited to QTcB &gt; 480 ms or 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>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 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 5, 2014</last_update_submitted>
  <last_update_submitted_qc>August 5, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 7, 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/NCT02211144
org study id: 1175.21
nct id: NCT02211144
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 (pulse rate, systolic and diastolic blood pressure)
time frame: up to day 21
measure: Number of patients with clinically relevant changes in laboratory parameters
time frame: up to day 21
measure: Number of patients with clinical relevant findings in electrocardiogram (ECG)
time frame: up to day 21
measure: Number of patients with adverse events
time frame: up to 35 days
measure: Clinical assessment of tolerability on a 4-point scale
time frame: day 21
measure: Maximum observed plasma concentration during steady state dosing interval (Cmax,ss)
time frame: up to day 16
measure: area under the plasma concentration versus time curve at different time points (AUC)
time frame: up to day 16
measure: Time to the maximum plasma concentration at steady state (tmax,ss)
time frame: up to day 16
measure: Elimination half-life (t1/2)
time frame: up to day 16
measure: Terminal elimination rate constant (λz)
time frame: up to day 16
measure: Average steady state plasma concentration (Css)
time frame: up to day 16
measure: Mean residence time (MRT)
time frame: up to day 16
measure: Total apparent oral clearance of drug from plasma after oral administration (CL/F )
time frame: up to day 16
measure: Apparent volume of distribution based on terminal elimination phase, divided by F (bioavailability factor) (Vz/F)
time frame: up to day 16
measure: Morning trough plasma concentration prior day 14
time frame: on day 2, 3, 5, 7, 9, 13 and 14
arm group label: BIRB 796 BS
arm group type: Experimental
description: in escalating doses
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: BIBR 796 BS
arm group label: BIRB 796 BS
intervention type: Drug
intervention name: Placebo
arm group label: BIRB 796 BS
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor