<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/NCT02222961</url>
  </required_header>
  <id_info>
    <org_study_id>600.2</org_study_id>
    <nct_id>NCT02222961</nct_id>
  </id_info>
  <brief_title>Single Increasing Dose Followed by Maintenance Dose Tolerance Study of BIIR 561 CL in Healthy Male Volunteers</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 as Loading Dose (Dosage: 37.5 mg/h - 150 mg/h, Infusion Time 1 Hour) Followed by Maintenance Dose (Dosage: 20 mg/h - 40 to 125 mg/h), Infusion Time 5 Hours</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 present study is to obtain information about the safety, tolerability&#xD;
      and pharmacokinetics of BIIR 561 after continuous intravenous administration of increasing&#xD;
      doses in healthy young volunteers&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 1999</start_date>
  <primary_completion_date type="Actual">June 2000</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 8 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 8 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 8 days 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 8 days after drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum concentration in plasma (Cmax)</measure>
    <time_frame>up to 32 hours after first drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to maximum concentration in plasma (tmax)</measure>
    <time_frame>up to 32 hours after first drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal half-life (t1/2)</measure>
    <time_frame>up to 32 hours after first drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration-time curve from zero to the last time points with a quantifiable plasma concentration (AUC0-tf)</measure>
    <time_frame>up to 32 hours after first drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration-time curve extrapolated to infinity (AUC0-inf)</measure>
    <time_frame>up to 32 hours after first drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Mean residence time (MRTtot)</measure>
    <time_frame>up to 32 hours after first drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total plasma clearance (CLtot)</measure>
    <time_frame>up to 32 hours after first drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of distribution (Vz)</measure>
    <time_frame>up to 32 hours after first drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of distribution at steady state (Vss)</measure>
    <time_frame>up to 32 hours after first drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount excreted into urine (Ae)</measure>
    <time_frame>up to 32 hours after first drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean residence time of disposition (MRTdisp)</measure>
    <time_frame>up to 32 hours after first drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal clearance (CLR)</measure>
    <time_frame>up to 32 hours after first drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment>60</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 months&#xD;
             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/NCT02222961
org study id: 600.2
nct id: NCT02222961
lead sponsor: 
The objective of the present study is to obtain information about the safety, tolerability
      and pharmacokinetics of BIIR 561 after continuous intravenous administration of increasing
      doses in healthy young volunteers
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single
measure: Number of subjects with adverse events
time frame: up to 8 days after drug administration
measure: Number of subjects with clinically significant findings in vital functions
time frame: up to 8 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 8 days after drug administration
measure: Number of subjects with clinically significant findings in laboratory tests
time frame: up to 8 days after drug administration
measure: Maximum concentration in plasma (Cmax)
time frame: up to 32 hours after first drug administration
measure: Time to maximum concentration in plasma (tmax)
time frame: up to 32 hours after first drug administration
measure: Terminal half-life (t1/2)
time frame: up to 32 hours after first drug administration
measure: Area under the plasma concentration-time curve from zero to the last time points with a quantifiable plasma concentration (AUC0-tf)
time frame: up to 32 hours after first drug administration
measure: Area under the plasma concentration-time curve extrapolated to infinity (AUC0-inf)
time frame: up to 32 hours after first drug administration
measure: Total Mean residence time (MRTtot)
time frame: up to 32 hours after first drug administration
measure: Total plasma clearance (CLtot)
time frame: up to 32 hours after first drug administration
measure: Volume of distribution (Vz)
time frame: up to 32 hours after first drug administration
measure: Volume of distribution at steady state (Vss)
time frame: up to 32 hours after first drug administration
measure: Amount excreted into urine (Ae)
time frame: up to 32 hours after first drug administration
measure: Mean residence time of disposition (MRTdisp)
time frame: up to 32 hours after first drug administration
measure: Renal clearance (CLR)
time frame: up to 32 hours after first 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