<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/NCT02222974</url>
  </required_header>
  <id_info>
    <org_study_id>600.1</org_study_id>
    <nct_id>NCT02222974</nct_id>
  </id_info>
  <brief_title>Single Increasing Dose Tolerance Study in Healthy Male Volunteers of BIIR 561 CL</brief_title>
  <official_title>A Single-blind, Placebo-controlled Single Increasing Dose Tolerance Study in Healthy Male Volunteers After Intravenous Administration of BIIR 561 CL (Dosage: 1mg/h - 175 mg/h), Infusion Time 1 Hour</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      The objective of the study is to obtain information about safety, tolerability and&#xD;
      pharmacokinetics of BIIR 561 CL after single intravenous administration of increasing doses&#xD;
      in healthy male volunteers&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 1999</start_date>
  <primary_completion_date type="Actual">August 1999</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>Single</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of subjects with adverse events</measure>
    <time_frame>up to 9 days after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with clinically significant findings in vital functions</measure>
    <time_frame>up to 9 days after drug administration</time_frame>
    <description>blood pressure, pulse rate, respiratory rate, oral body temperature</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with clinically significant findings in ECG</measure>
    <time_frame>up to 9 days after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with clinically significant findings in EEG</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with clinically significant findings in laboratory tests</measure>
    <time_frame>up to 9 days after drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration time curve (AUC)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum drug plasma concentration (Cmax)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to peak drug plasma concentration (tmax)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total mean residence time (MRTtot)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean residence time of disposition (MRTdisp)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent terminal half-life (t1/2)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total clearance (CLtot)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of distribution during the terminal phase (Vz)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of distribution at steady state (Vss)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal clearance (CLR)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount excreted into urine (Ae)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">84</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>BIIR 561 CL</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>BIIR 561 CL</intervention_name>
    <arm_group_label>BIIR 561 CL</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 male volunteers&#xD;
&#xD;
          -  Age 21 to 50 years&#xD;
&#xD;
          -  Broca index from -20% to +20%&#xD;
&#xD;
          -  Written informed consent prior to admission to the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medical examination, laboratory tests or ECG judged by the investigator to differ&#xD;
             significantly from normal clinical values&#xD;
&#xD;
          -  Known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological or hormonal disorders&#xD;
&#xD;
          -  Known diseases of the central nervous system (CNS) (such as epilepsy), CNS trauma in&#xD;
             their medical history or with psychiatric or neurological disorders&#xD;
&#xD;
          -  Known history of orthostatic hypotension, fainting spells or blackouts&#xD;
&#xD;
          -  Chronic or relevant acute infections&#xD;
&#xD;
          -  Allergy/hypersensitivity (including drug allergy) which is deemed relevant to the&#xD;
             trial as judged by the investigator&#xD;
&#xD;
          -  Intake of a drug 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&#xD;
&#xD;
          -  Intake of any other drug which might influence the results of the trial during the&#xD;
             week previous to the start of the study&#xD;
&#xD;
          -  Participation in another study with an investigational drug within the last two -&#xD;
             months preceding this study&#xD;
&#xD;
          -  Smoker (&gt; 10 cigarettes or 3 cigars or 3 pipes/day)&#xD;
&#xD;
          -  Alcohol use of more than 60 g per day&#xD;
&#xD;
          -  Drug dependency&#xD;
&#xD;
          -  Excessive physical activities (e.g. competitive sports) within the last week before&#xD;
             the study&#xD;
&#xD;
          -  Blood donation within the last 4 weeks (&gt;= 100 ml)&#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>August 2014</verification_date>
  <study_first_submitted>August 21, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <last_update_submitted>August 21, 2014</last_update_submitted>
  <last_update_submitted_qc>August 21, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 22, 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/NCT02222974
org study id: 600.1
nct id: NCT02222974
lead sponsor: 
The objective of the study is to obtain information about safety, tolerability and
      pharmacokinetics of BIIR 561 CL after single intravenous administration of increasing doses
      in healthy male volunteers
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single
measure: Number of subjects with adverse events
time frame: up to 9 days after drug administration
measure: Number of subjects with clinically significant findings in vital functions
time frame: up to 9 days after drug administration
description: blood pressure, pulse rate, respiratory rate, oral body temperature
measure: Number of subjects with clinically significant findings in ECG
time frame: up to 9 days after drug administration
measure: Number of subjects with clinically significant findings in EEG
time frame: up to 24 hours after drug administration
measure: Number of subjects with clinically significant findings in laboratory tests
time frame: up to 9 days after drug administration
measure: Area under the concentration time curve (AUC)
time frame: up to 24 hours after drug administration
measure: Maximum drug plasma concentration (Cmax)
time frame: up to 24 hours after drug administration
measure: Time to peak drug plasma concentration (tmax)
time frame: up to 24 hours after drug administration
measure: Total mean residence time (MRTtot)
time frame: up to 24 hours after drug administration
measure: Mean residence time of disposition (MRTdisp)
time frame: up to 24 hours after drug administration
measure: Apparent terminal half-life (t1/2)
time frame: up to 24 hours after drug administration
measure: Total clearance (CLtot)
time frame: up to 24 hours after drug administration
measure: Volume of distribution during the terminal phase (Vz)
time frame: up to 24 hours after drug administration
measure: Volume of distribution at steady state (Vss)
time frame: up to 24 hours after drug administration
measure: Renal clearance (CLR)
time frame: up to 24 hours after drug administration
measure: Amount excreted into urine (Ae)
time frame: up to 24 hours after drug administration
arm group label: BIIR 561 CL
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: BIIR 561 CL
arm group label: BIIR 561 CL
intervention type: Drug
intervention name: Placebo
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