<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/NCT02256709</url>
  </required_header>
  <id_info>
    <org_study_id>1214.1</org_study_id>
    <nct_id>NCT02256709</nct_id>
  </id_info>
  <brief_title>Safety, Tolerability and Pharmacokinetics of Oral BIBP 5371 CL in Healthy Male and Female Volunteers</brief_title>
  <official_title>Safety, Tolerability and Pharmacokinetics of BIBP 5371 CL Following Oral Administration to Healthy Male and Female Volunteers (Dose Range: 10 - 350 mg). A Double-blind (Within Treatment Groups), Randomised, Placebo-controlled, Single Rising Dose Study, Including Comparisons of 50 mg vs. 100 mg Tablet and Tablet vs. Drinking Solution, and Investigation of Food Effect</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Safety, tolerability and pharmacokinetics (including comparisons of different formulations&#xD;
      and investigation of food effect)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2004</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>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with changes in vital signs</measure>
    <time_frame>baseline, up to 8 days after drug administration</time_frame>
    <description>blood pressure, pulse rate, respiratory rate, body temperature</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with changes in electrocardiogram (ECG)</measure>
    <time_frame>baseline, up to 8 days after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with changes in safety laboratory parameters</measure>
    <time_frame>baseline, up to 8 days after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>baseline, up to 8 days after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Global tolerability assessment by the investigator on a verbal rating scale</measure>
    <time_frame>up to 8 days after drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cmax (maximum concentration of the analyte in plasma)</measure>
    <time_frame>up to 32 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tmax (time from dosing to maximum concentration)</measure>
    <time_frame>up to 32 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)</measure>
    <time_frame>up to 32 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>%AUC0-tz (the percentage of the AUC0-∞ that is obtained by extrapolation)</measure>
    <time_frame>up to 32 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>λz (terminal rate constant in plasma)</measure>
    <time_frame>up to 32 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2 (terminal half-life of the analyte in plasma)</measure>
    <time_frame>up to 32 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRTpo (mean residence time of the analyte in the body after po administration)</measure>
    <time_frame>up to 32 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL/F (apparent clearance of the analyte in the plasma after extravascular administration)</measure>
    <time_frame>up to 32 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)</measure>
    <time_frame>up to 32 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)</measure>
    <time_frame>up to 32 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)</measure>
    <time_frame>up to 32 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)</measure>
    <time_frame>up to 32 hours after drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>8</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>single rising dose BIBP 5371 CL</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>BIBP 5371 CL tablet high dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>to be compared with same daily dose level from single rising dose arm</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BIBP 5371 CL tablet low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>to be compared with same daily dose level from single rising dose arm</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo drinking solution</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>BIBP 5371 CL drinking solution</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>BIBP 5371 CL tablet high dose with food</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>BIBP 5371 CL tablet low dose with food</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo tablet</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BIBP 5371 CL tablet</intervention_name>
    <description>single rising daily doses</description>
    <arm_group_label>single rising dose BIBP 5371 CL</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BIBP 5371 CL solution</intervention_name>
    <arm_group_label>BIBP 5371 CL drinking solution</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High fat, high caloric breakfast</intervention_name>
    <arm_group_label>BIBP 5371 CL tablet high dose with food</arm_group_label>
    <arm_group_label>BIBP 5371 CL tablet low dose with food</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo tablet</intervention_name>
    <arm_group_label>Placebo tablet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BIBP 5371 CL tablet high dose</intervention_name>
    <arm_group_label>BIBP 5371 CL tablet high dose</arm_group_label>
    <arm_group_label>BIBP 5371 CL tablet high dose with food</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo drinking solution</intervention_name>
    <arm_group_label>Placebo drinking solution</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BIBP 5371 CL tablet low dose</intervention_name>
    <arm_group_label>BIBP 5371 CL tablet low dose</arm_group_label>
    <arm_group_label>BIBP 5371 CL tablet low dose with food</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male and female volunteers&#xD;
&#xD;
          -  Age 21 - 50 years&#xD;
&#xD;
          -  Body mass index (BMI) 18.5 - 29.9 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any finding of the medical examination (including blood pressure, pulse rate,&#xD;
             respiratory rate, body temperature and ECG) deviating from normal&#xD;
&#xD;
          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological or hormonal disorders&#xD;
&#xD;
          -  Diseases of the central nervous system or psychiatric disorders or neurological&#xD;
             disorders&#xD;
&#xD;
          -  History of relevant 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 1 month or less&#xD;
             than 10 half-lives of the respective drug before enrolment in the study&#xD;
&#xD;
          -  Use of any drugs which might influence the results of the trial (within 1 week prior&#xD;
             to administration or during the trial)&#xD;
&#xD;
          -  Participation in another trial with an investigational drug (within 2 months prior to&#xD;
             administration or during the trial)&#xD;
&#xD;
          -  Smoker (&gt; 10 cigarettes or &gt; 3 cigars or &gt; 3 pipes/day)&#xD;
&#xD;
          -  Inability to refrain from smoking on trial days&#xD;
&#xD;
          -  Alcohol abuse (&gt; 60 grams/day)&#xD;
&#xD;
          -  Drug abuse&#xD;
&#xD;
          -  Blood donation (≥ 100 mL within 4 weeks prior to administration or during the trial)&#xD;
&#xD;
          -  Excessive physical activities (within the last week before the study)&#xD;
&#xD;
          -  Any laboratory value outside the reference range of clinical relevance&#xD;
&#xD;
        In addition, for female subjects:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Positive pregnancy test&#xD;
&#xD;
          -  No adequate contraception e.g. oral contraceptives, intrauterine device, sterilisation&#xD;
&#xD;
        Females, who are not surgically sterile will be asked to additionally use barrier&#xD;
        contraception methods (e.g. condoms) prior to administration of study medication, during&#xD;
        the study and at least 1 month after release from the study&#xD;
&#xD;
          -  Inability to maintain this adequate contraception during the whole study period&#xD;
&#xD;
          -  Lactation period&#xD;
      </textblock>
    </criteria>
    <gender>All</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>October 2014</verification_date>
  <study_first_submitted>October 2, 2014</study_first_submitted>
  <study_first_submitted_qc>October 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 6, 2014</study_first_posted>
  <last_update_submitted>October 2, 2014</last_update_submitted>
  <last_update_submitted_qc>October 2, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 6, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pharmaceutical Solutions</mesh_term>
  </intervention_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/NCT02256709
org study id: 1214.1
nct id: NCT02256709
lead sponsor: 
Safety, tolerability and pharmacokinetics (including comparisons of different formulations
      and investigation of food effect)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Number of patients with changes in vital signs
time frame: baseline, up to 8 days after drug administration
description: blood pressure, pulse rate, respiratory rate, body temperature
measure: Number of patients with changes in electrocardiogram (ECG)
time frame: baseline, up to 8 days after drug administration
measure: Number of patients with changes in safety laboratory parameters
time frame: baseline, up to 8 days after drug administration
measure: Number of patients with adverse events
time frame: baseline, up to 8 days after drug administration
measure: Global tolerability assessment by the investigator on a verbal rating scale
time frame: up to 8 days after drug administration
measure: Cmax (maximum concentration of the analyte in plasma)
time frame: up to 32 hours after drug administration
measure: tmax (time from dosing to maximum concentration)
time frame: up to 32 hours after drug administration
measure: AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
time frame: up to 32 hours after drug administration
measure: %AUC0-tz (the percentage of the AUC0-∞ that is obtained by extrapolation)
time frame: up to 32 hours after drug administration
measure: λz (terminal rate constant in plasma)
time frame: up to 32 hours after drug administration
measure: t1/2 (terminal half-life of the analyte in plasma)
time frame: up to 32 hours after drug administration
measure: MRTpo (mean residence time of the analyte in the body after po administration)
time frame: up to 32 hours after drug administration
measure: CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
time frame: up to 32 hours after drug administration
measure: Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
time frame: up to 32 hours after drug administration
measure: Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)
time frame: up to 32 hours after drug administration
measure: fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)
time frame: up to 32 hours after drug administration
measure: CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)
time frame: up to 32 hours after drug administration
arm group label: single rising dose BIBP 5371 CL
arm group type: Experimental
arm group label: BIBP 5371 CL tablet high dose
arm group type: Experimental
description: to be compared with same daily dose level from single rising dose arm
arm group label: BIBP 5371 CL tablet low dose
arm group type: Experimental
description: to be compared with same daily dose level from single rising dose arm
arm group label: Placebo drinking solution
arm group type: Placebo Comparator
arm group label: BIBP 5371 CL drinking solution
arm group type: Experimental
arm group label: BIBP 5371 CL tablet high dose with food
arm group type: Experimental
arm group label: BIBP 5371 CL tablet low dose with food
arm group type: Experimental
arm group label: Placebo tablet
arm group type: Placebo Comparator
intervention type: Drug
intervention name: BIBP 5371 CL tablet
description: single rising daily doses
arm group label: single rising dose BIBP 5371 CL
intervention type: Drug
intervention name: BIBP 5371 CL solution
arm group label: BIBP 5371 CL drinking solution
intervention type: Other
intervention name: High fat, high caloric breakfast
arm group label: BIBP 5371 CL tablet high dose with food
arm group label: BIBP 5371 CL tablet low dose with food
intervention type: Drug
intervention name: Placebo tablet
arm group label: Placebo tablet
intervention type: Drug
intervention name: BIBP 5371 CL tablet high dose
arm group label: BIBP 5371 CL tablet high dose
arm group label: BIBP 5371 CL tablet high dose with food
intervention type: Drug
intervention name: Placebo drinking solution
arm group label: Placebo drinking solution
intervention type: Drug
intervention name: BIBP 5371 CL tablet low dose
arm group label: BIBP 5371 CL tablet low dose
arm group label: BIBP 5371 CL tablet low dose with food
criteria: 
gender: All
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
mesh term: Pharmaceutical Solutions