<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/NCT02202512</url>
  </required_header>
  <id_info>
    <org_study_id>1333.43</org_study_id>
    <secondary_id>2014-000320-20</secondary_id>
    <nct_id>NCT02202512</nct_id>
  </id_info>
  <brief_title>Effect of Repeated Doses of BI 1060469 and BI 1021958 on Glomerular Filtration Rate (GFR) in Healthy Volunteers</brief_title>
  <official_title>Effect of Repeated Oral Doses of BI 1060469, BI 1021958 and Active Controls, Cimetidine and Naproxen, on Measured GFR Via Renal Clearance of Iohexol in Healthy Male Subjects (a Phase I Study; Single-blind, Randomized, Placebo-controlled Within BI Groups and Open-label for the Active Controls)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Main objective is to investigate the measured glomerular filtration rate (mGFR) as assessed&#xD;
      by iohexol clearance in healthy male normovolemic subjects after oral administration of&#xD;
      single and repeated doses of BI 1060469, and BI 1021958.&#xD;
&#xD;
      The secondary objective of this trial is to investigate the glomerular filtration rate (GFR)&#xD;
      as assessed by 24 hours creatinine clearance in healthy male normovolemic subjects after oral&#xD;
      administration of single and repeated doses of BI 1060469, and BI 1021958.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</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>measured glomerular filtration rate (mGFR) based on renal iohexol clearance</measure>
    <time_frame>up to day 11</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>measured urinary 24-hour creatinine clearance</measure>
    <time_frame>up to day 11</time_frame>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">53</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>BI 1060469 low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Low-Dose,Tablet,oral administration with 240 ml water,over 10 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BI 1060469 high dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High-Dose,Tablets,oral administration with 240 ml water, over 10 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cimetidine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Naproxen</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>BI 1021958</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High-Dose,Tablets,oral administration with 240 ml water, over 10 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>tablets</description>
    <arm_group_label>BI 1060469 low dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cimetidine</intervention_name>
    <arm_group_label>Cimetidine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>tablets</description>
    <arm_group_label>BI 1060469 high dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>tablets</description>
    <arm_group_label>BI 1021958</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 1060469 high dose</intervention_name>
    <description>tablets</description>
    <arm_group_label>BI 1060469 high dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 1060469 low dose</intervention_name>
    <description>tablets</description>
    <arm_group_label>BI 1060469 low dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Naproxen</intervention_name>
    <arm_group_label>Naproxen</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 1021958</intervention_name>
    <description>tablets</description>
    <arm_group_label>BI 1021958</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Healthy male subjects according to the investigators assessment, as based on the&#xD;
             following criteria: a complete medical history including a physical examination, vital&#xD;
             signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and&#xD;
             clinical laboratory tests, including negative test result on occult blood in stool&#xD;
             (only for subjects assigned to Naproxen)&#xD;
&#xD;
          -  Age 18 to 45 years (incl.)&#xD;
&#xD;
          -  Body Mass Index (BMI) 18.5 to 29.9 kg/m2 (incl.)&#xD;
&#xD;
          -  Signed and dated written informed consent prior to admission to the study in&#xD;
             accordance with good clinical practice (GCP) and local legislation&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Any finding in the medical examination (including BP, PR or ECG) deviating from normal&#xD;
             and judged clinically relevant by the investigator&#xD;
&#xD;
          -  Repeated measurement of systolic blood pressure greater than 140 mm Hg, diastolic&#xD;
             blood pressure greater than 90 mm Hg, or pulse rate outside the range of 50 to 90 mmHg&#xD;
&#xD;
          -  Any laboratory value outside the reference range that the investigator considers to be&#xD;
             of clinical relevance&#xD;
&#xD;
          -  Serum creatinine laboratory value out of the normal range&#xD;
&#xD;
          -  GFR (Glomerular Filtration Rate) &lt; 90 mL/ min at screening&#xD;
&#xD;
          -  Urinary toral protein/creatinine ratio &gt; 0,1 mg protein/ mg creatinine&#xD;
&#xD;
          -  Current or history of relevant kidney, urinary tract diseases or abnormalities (i.e.&#xD;
             nephrolithiasis, hydronephrosis, acute or chronic nephritis, renal injury, renal&#xD;
             failure, infections)&#xD;
&#xD;
          -  Further exclusion criteria may apply&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Boehringer Ingelheim</last_name>
    <role>Study Chair</role>
    <affiliation>Boehringer Ingelheim</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>1333.43.1 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <last_update_submitted>December 23, 2014</last_update_submitted>
  <last_update_submitted_qc>December 23, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 24, 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>Naproxen</mesh_term>
    <mesh_term>Cimetidine</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/NCT02202512
org study id: 1333.43
secondary id: 2014-000320-20
nct id: NCT02202512
lead sponsor: 
Main objective is to investigate the measured glomerular filtration rate (mGFR) as assessed
      by iohexol clearance in healthy male normovolemic subjects after oral administration of
      single and repeated doses of BI 1060469, and BI 1021958.

      The secondary objective of this trial is to investigate the glomerular filtration rate (GFR)
      as assessed by 24 hours creatinine clearance in healthy male normovolemic subjects after oral
      administration of single and repeated doses of BI 1060469, and BI 1021958.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single
measure: measured glomerular filtration rate (mGFR) based on renal iohexol clearance
time frame: up to day 11
measure: measured urinary 24-hour creatinine clearance
time frame: up to day 11
arm group label: BI 1060469 low dose
arm group type: Experimental
description: Low-Dose,Tablet,oral administration with 240 ml water,over 10 days
arm group label: BI 1060469 high dose
arm group type: Experimental
description: High-Dose,Tablets,oral administration with 240 ml water, over 10 days
arm group label: Cimetidine
arm group type: Active Comparator
arm group label: Naproxen
arm group type: Active Comparator
arm group label: BI 1021958
arm group type: Experimental
description: High-Dose,Tablets,oral administration with 240 ml water, over 10 days
intervention type: Drug
intervention name: Placebo
description: tablets
arm group label: BI 1060469 low dose
intervention type: Drug
intervention name: Cimetidine
arm group label: Cimetidine
intervention type: Drug
intervention name: Placebo
description: tablets
arm group label: BI 1060469 high dose
intervention type: Drug
intervention name: Placebo
description: tablets
arm group label: BI 1021958
intervention type: Drug
intervention name: BI 1060469 high dose
description: tablets
arm group label: BI 1060469 high dose
intervention type: Drug
intervention name: BI 1060469 low dose
description: tablets
arm group label: BI 1060469 low dose
intervention type: Drug
intervention name: Naproxen
arm group label: Naproxen
intervention type: Drug
intervention name: BI 1021958
description: tablets
arm group label: BI 1021958
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Boehringer Ingelheim
role: Study Chair
affiliation: Boehringer Ingelheim
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Naproxen
mesh term: Cimetidine