<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/NCT02254070</url>
  </required_header>
  <id_info>
    <org_study_id>1192.12</org_study_id>
    <nct_id>NCT02254070</nct_id>
  </id_info>
  <brief_title>Influence of Different Degrees of Renal Impairment on the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of BIBT 986 BS in Subjects With Normal Renal Function and Patients With Different Degrees of Renal Impairment</brief_title>
  <official_title>Influence of Different Degrees of Renal Impairment on the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of 1.0 mg of BIBT 986 BS Given as a Single Dose Infusion Over 30 Minutes in Subjects With Normal Renal Function and Patients With Different Degrees of Renal Impairment in an Open, Group Comparison Design</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      To assess the influence of different degrees of renal impairment on safety, tolerability,&#xD;
      pharmacodynamics and pharmacokinetics of 1.0 mg of BIBT 986 BS given as a single dose&#xD;
      infusion over 30 minutes in comparison to a normal renal function&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2003</start_date>
  <primary_completion_date type="Actual">August 2004</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum measured concentration of the analyte in plasma (Cmax)</measure>
    <time_frame>Up to 48 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to reach the maximum concentration of the analyte in plasma (tmax)</measure>
    <time_frame>Up to 48 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Total area under the plasma drug concentration-time curve from time zero to infinity (AUC0-∞)</measure>
    <time_frame>Up to 48 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the concentration-time curve of the analyte in plasma from zero time to the time of the last quantifiable drug concentration (AUC0-tz)</measure>
    <time_frame>Up to 48 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Terminal rate constant of the analyte in plasma (λz)</measure>
    <time_frame>Up to 48 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Terminal half-life of the analyte in plasma (t1/2)</measure>
    <time_frame>Up to 48 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean residence time of the analyte in the body after intravenous infusion (MRTinf)</measure>
    <time_frame>Up to 48 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Total clearance of the analyte from plasma following intravascular administration (CL)</measure>
    <time_frame>Up to 48 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent volume of distribution at steady state following an intravascular dose (Vss)</measure>
    <time_frame>Up to 48 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent volume of distribution during the terminal phase λz following an intravascular dose (Vz)</measure>
    <time_frame>Up to 48 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Amount of drug excreted in the urine (Ae)</measure>
    <time_frame>Up to 48 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in activated partial thromboplastin time (aPTT)</measure>
    <time_frame>Up to 48 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in ecarin clotting time (ECT)</measure>
    <time_frame>Up to 48 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in International Normalized Ratio (INR)</measure>
    <time_frame>Up to 48 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in thrombin time (TT)</measure>
    <time_frame>Up to 48 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma concentration of the analyte at the end of the intravenous infusion (CT)</measure>
    <time_frame>29 minutes after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with clinically significant changes in vital signs</measure>
    <time_frame>Up to 3 days after drug administration</time_frame>
    <description>Blood pressure and pulse rate</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with clinically significant changes in ECG (electrocardiogram)</measure>
    <time_frame>Up to 3 days after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with abnormal changes in clinical laboratory parameters</measure>
    <time_frame>Up to 3 days after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with adverse events</measure>
    <time_frame>Up to 3 days after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in prothrombin time (PT)</measure>
    <time_frame>Up to 48 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>partial area under the concentration time curve (from time 0 to last sampling time preceding hemodialysis in any of the patients) (AUCt1-t2)</measure>
    <time_frame>Up to 48 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>fraction of administered drug excreted unchanged in urine over the respective time interval (fe)</measure>
    <time_frame>Up to 48 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Renal clearance of the analyte from plasma following intravascular administration (CLR)</measure>
    <time_frame>Up to 48 hours after drug administration</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>BIBT 986 BS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BIBT 986 BS</intervention_name>
    <arm_group_label>BIBT 986 BS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male or female subjects determined by results of screening with a creatinine&#xD;
             clearance &gt;80 mL/min (Group 1)&#xD;
&#xD;
          -  Renally impaired male or female subjects determined by results of screening with the&#xD;
             following creatinine clearance results:&#xD;
&#xD;
               -  creatinine clearance 51-80 mL/min (Group 2)&#xD;
&#xD;
               -  creatinine clearance 31-50 mL/min (Group 3)&#xD;
&#xD;
               -  creatinine clearance ≤ 30 mL/min (Group 4)&#xD;
&#xD;
               -  subjects requiring hemodialysis (Group 5)&#xD;
&#xD;
          -  Signed written informed consent in accordance with Good Clinical Practice (GCP) and&#xD;
             local legislation&#xD;
&#xD;
          -  Age &gt;=18 and &lt;=75 years&#xD;
&#xD;
          -  BMI &gt;=18.5 and &lt;=29.9 kg/m2 for Groups 1+2&#xD;
&#xD;
          -  BMI &gt;=18.5 and &lt;=32 kg/m2 for Groups 3, 4 and 5&#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;
          -  Abnormal PT, TT, aPTT (must be within the normal range after no more than one repeated&#xD;
             test), thrombocytes &lt; 150000/μl (two repeats of the first test)&#xD;
&#xD;
          -  Evidence of haematuria either macroscopically detectable or microscopic on urinalysis&#xD;
             (normal microscopic results after no ore than one repeated test)&#xD;
&#xD;
          -  Evidence of blood dyscrasia, haemorrhagic diathesis, severe thrombocytopenia,&#xD;
             cerebrovascular haemorrhage, bleeding tendencies associated with active ulceration or&#xD;
             overt bleeding of gastrointestinal, respiratory or genitourinary tract or any disease&#xD;
             or condition with haemorrhagic tendencies (e.g. cerebral aneurysm, dissecting aorta,&#xD;
             CNS trauma, retinopathy, nephrolithiasis)&#xD;
&#xD;
          -  Recent or contemplated diagnostic or therapeutic procedures with potential for&#xD;
             uncontrollable bleeding (e.g. spinal puncture, lumbar block anaesthesia, surgery of&#xD;
             central nervous system (CNS) or eye or surgery resulting in large open surfaces)&#xD;
             within 14 days before or after drug administration of this clinical trial&#xD;
&#xD;
          -  Occult blood in 1 of 3 subsequent faecal samples collected for the pre-study&#xD;
             examination&#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;
          -  For women with childbearing potential: no reliable contraception (accepted methods are&#xD;
             intra uterine device, hormonal contraceptives, bilateral tubal ligation, hysterectomy,&#xD;
             condoms) or pregnancy (known or detected by a positive pregnancy test) or breast&#xD;
             feeding period&#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, within 14 days prior to 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;
          -  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;
          -  Veins unsuited for i.v. puncture and administration of prolonged infusions on either&#xD;
             arm (e.g. veins which are difficult to locate, access or puncture, veins with a&#xD;
             tendency to rupture during or after puncture, etc.)&#xD;
&#xD;
        Renally impaired subjects (Group 2, 3, 4 and 5) who meet any of the following criteria will&#xD;
        not be entered into this trial:&#xD;
&#xD;
          -  Moderate and severe concurrent liver function impairment (e.g., due to hepatorenal&#xD;
             syndrome)&#xD;
&#xD;
          -  Gastrointestinal, respiratory, cardiovascular, metabolic, immunologic or hormonal&#xD;
             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;
          -  Abnormal values for PT, TT, aPTT and thrombocytes considered by the investigator or&#xD;
             one of the co-investigators to be clinically relevant&#xD;
&#xD;
          -  Hemoglobin concentration &lt;9 mg/dl&#xD;
&#xD;
          -  Evidence of blood dyscrasia, haemorrhagic diathesis, severe thrombocytopenia,&#xD;
             cerebrovascular haemorrhage, bleeding tendencies associated with active ulceration or&#xD;
             overt bleeding of gastrointestinal, respiratory or genitourinary tract or any disease&#xD;
             or condition with haemorrhagic tendencies (e.g. cerebral aneurysm, dissecting&#xD;
             aorta,CNS trauma, retinopathy, nephrolithiasis) considered by the investigator or one&#xD;
             of the co-investigators to be clinically relevant&#xD;
&#xD;
          -  Recent or contemplated diagnostic or therapeutic procedures with potential for&#xD;
             uncontrollable bleeding (e.g. spinal puncture, lumbar block anaesthesia, surgery of&#xD;
             CNS or eye or surgery resulting in large open surfaces) within 14 days before or after&#xD;
             drug administration of this clinical trial&#xD;
&#xD;
          -  Occult blood in 1 of 3 subsequent faecal samples collected for the pre-study&#xD;
             examination&#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;
          -  For women with childbearing potential: no reliable contraception (accepted methods are&#xD;
             intra uterine device, hormonal contraceptives, bilateral tubal ligation, hysterectomy,&#xD;
             condoms) or pregnancy (known or detected by a positive pregnancy test) or breast&#xD;
             feeding period&#xD;
&#xD;
          -  Faecal occult blood (FOB) in 1 of 3 subsequent samples collected for the pre-study&#xD;
             examination&#xD;
&#xD;
          -  Use of any drugs which have an influence on the blood clotting within 14 days prior to&#xD;
             administration or during the trial (except heparin for hemodialysis patients)&#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;
          -  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;
          -  Veins unsuited for i.v. puncture and administration of prolonged infusions on either&#xD;
             arm (e.g. veins which are difficult to locate, access or puncture, veins with a&#xD;
             tendency to rupture during or after puncture, etc.)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 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>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Renal Insufficiency</mesh_term>
  </condition_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/NCT02254070
org study id: 1192.12
nct id: NCT02254070
lead sponsor: 
To assess the influence of different degrees of renal impairment on safety, tolerability,
      pharmacodynamics and pharmacokinetics of 1.0 mg of BIBT 986 BS given as a single dose
      infusion over 30 minutes in comparison to a normal renal function
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum measured concentration of the analyte in plasma (Cmax)
time frame: Up to 48 hours after drug administration
measure: Time to reach the maximum concentration of the analyte in plasma (tmax)
time frame: Up to 48 hours after drug administration
measure: Total area under the plasma drug concentration-time curve from time zero to infinity (AUC0-∞)
time frame: Up to 48 hours after drug administration
measure: Area under the concentration-time curve of the analyte in plasma from zero time to the time of the last quantifiable drug concentration (AUC0-tz)
time frame: Up to 48 hours after drug administration
measure: Terminal rate constant of the analyte in plasma (λz)
time frame: Up to 48 hours after drug administration
measure: Terminal half-life of the analyte in plasma (t1/2)
time frame: Up to 48 hours after drug administration
measure: Mean residence time of the analyte in the body after intravenous infusion (MRTinf)
time frame: Up to 48 hours after drug administration
measure: Total clearance of the analyte from plasma following intravascular administration (CL)
time frame: Up to 48 hours after drug administration
measure: Apparent volume of distribution at steady state following an intravascular dose (Vss)
time frame: Up to 48 hours after drug administration
measure: Apparent volume of distribution during the terminal phase λz following an intravascular dose (Vz)
time frame: Up to 48 hours after drug administration
measure: Amount of drug excreted in the urine (Ae)
time frame: Up to 48 hours after drug administration
measure: Change in activated partial thromboplastin time (aPTT)
time frame: Up to 48 hours after drug administration
measure: Change in ecarin clotting time (ECT)
time frame: Up to 48 hours after drug administration
measure: Change in International Normalized Ratio (INR)
time frame: Up to 48 hours after drug administration
measure: Change in thrombin time (TT)
time frame: Up to 48 hours after drug administration
measure: Plasma concentration of the analyte at the end of the intravenous infusion (CT)
time frame: 29 minutes after drug administration
measure: Number of participants with clinically significant changes in vital signs
time frame: Up to 3 days after drug administration
description: Blood pressure and pulse rate
measure: Number of participants with clinically significant changes in ECG (electrocardiogram)
time frame: Up to 3 days after drug administration
measure: Number of participants with abnormal changes in clinical laboratory parameters
time frame: Up to 3 days after drug administration
measure: Number of participants with adverse events
time frame: Up to 3 days after drug administration
measure: Change in prothrombin time (PT)
time frame: Up to 48 hours after drug administration
measure: partial area under the concentration time curve (from time 0 to last sampling time preceding hemodialysis in any of the patients) (AUCt1-t2)
time frame: Up to 48 hours after drug administration
measure: fraction of administered drug excreted unchanged in urine over the respective time interval (fe)
time frame: Up to 48 hours after drug administration
measure: Renal clearance of the analyte from plasma following intravascular administration (CLR)
time frame: Up to 48 hours after drug administration
arm group label: BIBT 986 BS
arm group type: Experimental
intervention type: Drug
intervention name: BIBT 986 BS
arm group label: BIBT 986 BS
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Renal Insufficiency