<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/NCT02244203</url>
  </required_header>
  <id_info>
    <org_study_id>1267.1</org_study_id>
    <nct_id>NCT02244203</nct_id>
  </id_info>
  <brief_title>Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 60732 in Healthy Male Volunteers</brief_title>
  <official_title>Investigation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of 0.25, 0.5, 1, 2, 4, 20, 50, 100, 150 and 200 mg BI 60732 Powder in Bottle (PIB) Administered to Healthy Male Volunteers in a Randomised, Double Blind, Placebo Controlled Phase I Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Single Rising Dose (SRD) study: First evaluation of safety, tolerability, pharmacokinetics&#xD;
      and pharmacodynamics of BI 60732&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2009</start_date>
  <primary_completion_date type="Actual">July 2009</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>Single Group 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 vital signs (blood pressure (BP), pulse rate (PR))</measure>
    <time_frame>up to day 21 after start of treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with clinically relevant changes in 12-lead ECG</measure>
    <time_frame>up to day 21 after start of treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with clinically relevant changes in laboratory parameters</measure>
    <time_frame>up to day 21 after start of treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with clinically relevant changes in coagulation parameters</measure>
    <time_frame>up to 72 hours after start of treatment</time_frame>
    <description>Parameters:&#xD;
Activated partial thromboplastin time (aPTT)&#xD;
Prothrombin time (PT)&#xD;
HepTest®</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 6 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Global assessment of tolerability by investigator on a 4-point scale</measure>
    <time_frame>up to 21 days after start of treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum measured concentration of the analyte in plasma (Cmax)</measure>
    <time_frame>up to 264 hours after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time from dosing to maximum measured concentration of the analyte in plasma (tmax)</measure>
    <time_frame>up to 264 hours after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration-time curve of the analyte in plasma (AUC)</measure>
    <time_frame>up to 264 hours after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal rate constant of the analyte in plasma (λz)</measure>
    <time_frame>up to 264 hours after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal half-life of the analyte in plasma (t1/2)</measure>
    <time_frame>up to 264 hours after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean residence time of the analyte in the body after oral administration (MRTpo)</measure>
    <time_frame>up to 264 hours after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent clearance of the analyte in plasma after extravascular administration (CL/F)</measure>
    <time_frame>up to 264 hours after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of analyte eliminated in urine from the time point t1 to time point t2 (Aet1-t2)</measure>
    <time_frame>up to 264 hours after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fraction of analyte eliminated in urine from time point t1 to time point t2 (fet1-t2)</measure>
    <time_frame>up to 264 hours after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal clearance of the analyte from the time point t1 until the time point t2 (CLR,t1-t2)</measure>
    <time_frame>Pre-dose, up to 264 hours after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in activated partial thromboplastin time (aPTT)</measure>
    <time_frame>Pre-dose, up to 72 hours after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in prothrombin time (PT)</measure>
    <time_frame>Pre-dose, up to 72 hours after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prolongation of coagulation time by Heptest®</measure>
    <time_frame>up to 72 hours after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inhibition of FXa activity</measure>
    <time_frame>Pre-dose up to 168 hours after start of treatment</time_frame>
    <description>Russel's Viper Venom (RVV)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage inhibition of endogenous thrombin generation</measure>
    <time_frame>up to 24 hours after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage peak inhibition of thrombin generation</measure>
    <time_frame>up to 24 hours after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative prolongation of time to maximum inhibition of thrombin generation</measure>
    <time_frame>up to 24 hours after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative prolongation of lag time of thrombin generation</measure>
    <time_frame>up to 24 hours after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum effect (Emax)</measure>
    <time_frame>up to 168 hours after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to maximum effect (tmax)</measure>
    <time_frame>up to 168 hours after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the effect curve (AUEC)</measure>
    <time_frame>up to 168 hours after start of treatment</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Single rising doses of BI 60732</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>BI 60732</intervention_name>
    <arm_group_label>Single rising doses of BI 60732</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 males according to the following criteria: Based upon a complete medical&#xD;
             history, including the physical examination, vital signs (BP, PR), 12-lead ECG,&#xD;
             clinical laboratory tests&#xD;
&#xD;
          -  Age ≥ 18 and Age ≤ 45 years&#xD;
&#xD;
          -  BMI ≥ 18.5 and BMI ≤ 29.9 kg/m2 (Body Mass Index)&#xD;
&#xD;
          -  Signed and dated written informed consent prior to admission to the study in&#xD;
             accordance with good clinical practice and the local legislation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any finding of the medical examination deviating from normal and of clinical&#xD;
             relevance. Repeated measurement of a systolic blood pressure greater than 140 mm Hg or&#xD;
             diastolic blood pressure greater than 90 mm Hg&#xD;
&#xD;
          -  Any evidence of a clinically relevant concomitant disease&#xD;
&#xD;
          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological or hormonal disorders&#xD;
&#xD;
          -  Surgery of the 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 relevant orthostatic hypotension, fainting spells or blackouts&#xD;
&#xD;
          -  Chronic or relevant acute infections&#xD;
&#xD;
          -  History of relevant allergy/hypersensitivity (including allergy to drug or its&#xD;
             excipients)&#xD;
&#xD;
          -  Intake of drugs within one month or less than 10 half-lives of the respective drug&#xD;
             prior to first study drug administration except if a relevant interaction can be ruled&#xD;
             out&#xD;
&#xD;
          -  Participation in another trial with an investigational drug within 2 months prior to&#xD;
             first study drug administration&#xD;
&#xD;
          -  Smoker (&gt; 10 cigarettes or &gt; 3 cigars or &gt; 3 pipes/day)&#xD;
&#xD;
          -  Alcohol abuse (average consumption of more than 30 g / day)&#xD;
&#xD;
          -  Drug abuse&#xD;
&#xD;
          -  Blood donation (more than 100 mL within four weeks prior to the start of study)&#xD;
&#xD;
          -  Any laboratory value outside the reference range that is of clinical relevance&#xD;
&#xD;
          -  Inability to comply with dietary regimen of trial site&#xD;
&#xD;
          -  A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a&#xD;
             QTc interval &gt;450 ms)&#xD;
&#xD;
          -  A history of additional risk factors for Torsade de pointes (e.g., heart failure,&#xD;
             hypokalaemia, family history of Long QT Syndrome)&#xD;
&#xD;
          -  Anaemia at screening&#xD;
&#xD;
          -  Subjects who in the investigator's judgement are perceived as having an increased risk&#xD;
             of bleeding, for example because of:&#xD;
&#xD;
               -  Hemorrhagic disorders or bleeding diathesis&#xD;
&#xD;
               -  Occult blood in faeces or haematuria&#xD;
&#xD;
               -  Trauma or surgery within the last month or as long as an excessive risk of&#xD;
                  bleeding persists after these events, or planned surgery during trial&#xD;
                  participation&#xD;
&#xD;
               -  History of arteriovenous malformation or aneurysm&#xD;
&#xD;
               -  History of gastroduodenal ulcer disease or gastrointestinal haemorrhage&#xD;
&#xD;
               -  History of intracranial, intraocular, spinal, retroperitoneal, or atraumatic&#xD;
                  intraarticular bleeding&#xD;
&#xD;
               -  Use of drugs that may interfere with haemostasis during trial conduct (e.g.&#xD;
                  acetylsalicylic acid or other non-steroidal anti-inflammatory drugs)&#xD;
&#xD;
               -  Thrombocytopenia (platelet count &lt; 100/nL)&#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>September 2014</verification_date>
  <study_first_submitted>September 18, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>September 18, 2014</last_update_submitted>
  <last_update_submitted_qc>September 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 19, 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/NCT02244203
org study id: 1267.1
nct id: NCT02244203
lead sponsor: 
Single Rising Dose (SRD) study: First evaluation of safety, tolerability, pharmacokinetics
      and pharmacodynamics of BI 60732
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Double
measure: Number of patients with clinically relevant changes in vital signs (blood pressure (BP), pulse rate (PR))
time frame: up to day 21 after start of treatment
measure: Number of patients with clinically relevant changes in 12-lead ECG
time frame: up to day 21 after start of treatment
measure: Number of patients with clinically relevant changes in laboratory parameters
time frame: up to day 21 after start of treatment
measure: Number of patients with clinically relevant changes in coagulation parameters
time frame: up to 72 hours after start of treatment
description: Parameters:
Activated partial thromboplastin time (aPTT)
Prothrombin time (PT)
HepTest®
measure: Number of patients with adverse events
time frame: up to 6 weeks
measure: Global assessment of tolerability by investigator on a 4-point scale
time frame: up to 21 days after start of treatment
measure: Maximum measured concentration of the analyte in plasma (Cmax)
time frame: up to 264 hours after start of treatment
measure: Time from dosing to maximum measured concentration of the analyte in plasma (tmax)
time frame: up to 264 hours after start of treatment
measure: Area under the concentration-time curve of the analyte in plasma (AUC)
time frame: up to 264 hours after start of treatment
measure: Terminal rate constant of the analyte in plasma (λz)
time frame: up to 264 hours after start of treatment
measure: Terminal half-life of the analyte in plasma (t1/2)
time frame: up to 264 hours after start of treatment
measure: Mean residence time of the analyte in the body after oral administration (MRTpo)
time frame: up to 264 hours after start of treatment
measure: Apparent clearance of the analyte in plasma after extravascular administration (CL/F)
time frame: up to 264 hours after start of treatment
measure: Amount of analyte eliminated in urine from the time point t1 to time point t2 (Aet1-t2)
time frame: up to 264 hours after start of treatment
measure: Fraction of analyte eliminated in urine from time point t1 to time point t2 (fet1-t2)
time frame: up to 264 hours after start of treatment
measure: Renal clearance of the analyte from the time point t1 until the time point t2 (CLR,t1-t2)
time frame: Pre-dose, up to 264 hours after start of treatment
measure: Changes in activated partial thromboplastin time (aPTT)
time frame: Pre-dose, up to 72 hours after start of treatment
measure: Changes in prothrombin time (PT)
time frame: Pre-dose, up to 72 hours after start of treatment
measure: Prolongation of coagulation time by Heptest®
time frame: up to 72 hours after start of treatment
measure: Inhibition of FXa activity
time frame: Pre-dose up to 168 hours after start of treatment
description: Russel's Viper Venom (RVV)
measure: Percentage inhibition of endogenous thrombin generation
time frame: up to 24 hours after start of treatment
measure: Percentage peak inhibition of thrombin generation
time frame: up to 24 hours after start of treatment
measure: Relative prolongation of time to maximum inhibition of thrombin generation
time frame: up to 24 hours after start of treatment
measure: Relative prolongation of lag time of thrombin generation
time frame: up to 24 hours after start of treatment
measure: Maximum effect (Emax)
time frame: up to 168 hours after start of treatment
measure: Time to maximum effect (tmax)
time frame: up to 168 hours after start of treatment
measure: Area under the effect curve (AUEC)
time frame: up to 168 hours after start of treatment
arm group label: Single rising doses of BI 60732
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: BI 60732
arm group label: Single rising doses of BI 60732
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