<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/NCT02254538</url>
  </required_header>
  <id_info>
    <org_study_id>1188.1</org_study_id>
    <nct_id>NCT02254538</nct_id>
  </id_info>
  <brief_title>A Safety, Tolerability and Preliminary Pharmacokinetics of BILR 355 BS Single-rising Dose Study in Healthy Male Volunteers</brief_title>
  <official_title>A Double-blind (at Each Dose Level), Randomised, Placebo-controlled Single Increasing Dose Safety, Tolerability and Preliminary Pharmacokinetics Study in Healthy Male Volunteers After Oral Administration of BILR 355 BS Solved in PEG 400 (Dosage: 1 - 200 mg)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Assessment of safety, tolerability and preliminary pharmacokinetics in healthy male&#xD;
      volunteers after oral administration of BILR 355 BS&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2002</start_date>
  <primary_completion_date type="Actual">February 2003</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 participants with clinically significant changes in vital functions</measure>
    <time_frame>Up to 10 days after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with abnormal findings in ECG (electrocardiogram)</measure>
    <time_frame>Up to 10 days after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with abnormal findings in skin inspections</measure>
    <time_frame>Up to 10 days after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with abnormal neurological finding</measure>
    <time_frame>Up to 10 days after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with abnormal changes in laboratory parameters</measure>
    <time_frame>Up to 10 days after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with positive faecal occult blood testing</measure>
    <time_frame>Up to 10 days after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with adverse events</measure>
    <time_frame>Up to 10 days after drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum plasma concentration (Cmax)</measure>
    <time_frame>Up to 144 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to attain maximum plasma concentration (tmax)</measure>
    <time_frame>Up to 144 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration-time curve of the analyte in plasma from zero time to infinity (AUC0-∞)</measure>
    <time_frame>Up to 144 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal half life (t½)</measure>
    <time_frame>Up to 144 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent clearance of the analyte in plasma following extravascular administration (CL/F)</measure>
    <time_frame>Up to 144 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total mean residence time (MRTtot)</measure>
    <time_frame>Up to 144 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent volume of distribution during the terminal elimination phase (Vz/F)</measure>
    <time_frame>Up to 144 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal clearance of the analyte (CLR)</measure>
    <time_frame>Up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of drug excreted in the urine (Ae)</measure>
    <time_frame>Up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_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 144 hours after drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>BILR 355 BS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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>BILR 355 BS</intervention_name>
    <arm_group_label>BILR 355 BS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PEG 400</intervention_name>
    <arm_group_label>BILR 355 BS</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All participants in the study should be healthy males, ranging from 21 to 50 years of age&#xD;
        and their body mass index (BMI) be within 18.5 to 29.9 kg/m2 (BMI calculation: weight in&#xD;
        kilograms divided by the square of height in meters).&#xD;
&#xD;
        In accordance with Good clinical practice (GCP) and the local legislation all volunteers&#xD;
        will have given their written informed consent prior to admission to the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any finding 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,&#xD;
             immunological or hormonal disorders&#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;
          -  Intake of drugs with a long half-life (&gt; 24 hours) within at least one month or less&#xD;
             than ten half-lives of the respective drug before enrolment in the study or during the&#xD;
             study&#xD;
&#xD;
          -  Use of any drugs which might influence the results of the trial up to 7 days prior to&#xD;
             enrolment in the study or during the study&#xD;
&#xD;
          -  Participation in another trial with an investigational drug (≤ two months prior to&#xD;
             administration or during the trial)&#xD;
&#xD;
          -  Smoker (&gt; 10 cigarettes or &gt; 3 cigars of &gt; 3 pipes/day)&#xD;
&#xD;
          -  Inability to refrain from smoking on trial days&#xD;
&#xD;
          -  Alcohol abuse (&gt; 60 g/day)&#xD;
&#xD;
          -  Drug abuse&#xD;
&#xD;
          -  Blood donation (≥ 100 mL within four weeks prior to administration or during the&#xD;
             trial)&#xD;
&#xD;
          -  Any laboratory value outside the clinically accepted reference range&#xD;
&#xD;
          -  Excessive physical activities within the last week before the trial or during the&#xD;
             trial&#xD;
&#xD;
        Following exclusion criteria are of special interest for this study:&#xD;
&#xD;
        - Erythema, exanthema and comparable skin alterations&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>50 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 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <last_update_submitted>September 29, 2014</last_update_submitted>
  <last_update_submitted_qc>September 29, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 2, 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/NCT02254538
org study id: 1188.1
nct id: NCT02254538
lead sponsor: 
Assessment of safety, tolerability and preliminary pharmacokinetics in healthy male
      volunteers after oral administration of BILR 355 BS
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Number of participants with clinically significant changes in vital functions
time frame: Up to 10 days after drug administration
measure: Number of participants with abnormal findings in ECG (electrocardiogram)
time frame: Up to 10 days after drug administration
measure: Number of participants with abnormal findings in skin inspections
time frame: Up to 10 days after drug administration
measure: Number of participants with abnormal neurological finding
time frame: Up to 10 days after drug administration
measure: Number of participants with abnormal changes in laboratory parameters
time frame: Up to 10 days after drug administration
measure: Number of participants with positive faecal occult blood testing
time frame: Up to 10 days after drug administration
measure: Number of participants with adverse events
time frame: Up to 10 days after drug administration
measure: Maximum plasma concentration (Cmax)
time frame: Up to 144 hours after drug administration
measure: Time to attain maximum plasma concentration (tmax)
time frame: Up to 144 hours after drug administration
measure: Area under the concentration-time curve of the analyte in plasma from zero time to infinity (AUC0-∞)
time frame: Up to 144 hours after drug administration
measure: Terminal half life (t½)
time frame: Up to 144 hours after drug administration
measure: Apparent clearance of the analyte in plasma following extravascular administration (CL/F)
time frame: Up to 144 hours after drug administration
measure: Total mean residence time (MRTtot)
time frame: Up to 144 hours after drug administration
measure: Apparent volume of distribution during the terminal elimination phase (Vz/F)
time frame: Up to 144 hours after drug administration
measure: Renal clearance of the analyte (CLR)
time frame: Up to 72 hours after drug administration
measure: Amount of drug excreted in the urine (Ae)
time frame: Up to 72 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 144 hours after drug administration
arm group label: BILR 355 BS
arm group type: Experimental
description: escalating doses
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: BILR 355 BS
arm group label: BILR 355 BS
intervention type: Drug
intervention name: PEG 400
arm group label: BILR 355 BS
arm group label: Placebo
criteria: 
gender: Male
minimum age: 21 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor