<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/NCT03235076</url>
  </required_header>
  <id_info>
    <org_study_id>18745</org_study_id>
    <secondary_id>2017-001141-28</secondary_id>
    <nct_id>NCT03235076</nct_id>
  </id_info>
  <brief_title>Clinical Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Pharmacodynamic Effects of a Single Oral 10 mg BAY1101042 Tablet Dose in Men and Woman With Renal Impairment and in Healthy Subjects</brief_title>
  <official_title>Investigation of Pharmacokinetics, Safety, Tolerability and Pharmacodynamic Effects of a Single Oral 10 mg BAY1101042 MR Tablet Dose in Male and Female Subjects With Renal Impairment and in Age-, Gender-, and Weight- Matched Healthy Subjects in a Single Center, Non-controlled, Open-label, Observational Design</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bayer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate the pharmacokinetics of BAY1101042 in subjects with mild to severe renal&#xD;
      impairment, stratified according to estimated glomerular filtration rate (eGFR) determined&#xD;
      2-10 days prior to dosing, and age-, weight- and gender- matched healthy subjects and to&#xD;
      assess the safety, tolerability, and pharmacodynamics of BAY1101042 after a single oral dose&#xD;
      of a 10 mg BAY1101042 given as 5 mg modified release (MR) tablet.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 15, 2017</start_date>
  <completion_date type="Actual">March 13, 2019</completion_date>
  <primary_completion_date type="Actual">November 7, 2018</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under the concentration vs. time curve from zero to infinity after single dose (AUC) of BAY1101042</measure>
    <time_frame>Study Day 1 to Study Day 6</time_frame>
    <description>Area under the concentration vs. time curve from zero to infinity after single dose of BAY1101042</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of BAY1101042</measure>
    <time_frame>Study Day 1 to Study Day 6</time_frame>
    <description>Maximum observed concentration of BAY1101042 in plasma after single dose administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUCu of BAY1101042</measure>
    <time_frame>Study Day 1 to Study Day 6</time_frame>
    <description>Area under the unbound concentration vs. time curve from zero to infinity after single dose of BAY1101042</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax,u of BAY1101042</measure>
    <time_frame>Study Day 1 to Study Day 6</time_frame>
    <description>Maximum observed unbound concentration of BAY1101042 in plasma after single dose administration of BAY1101042</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Renal Impairment</condition>
  <arm_group>
    <arm_group_label>Subjects with mild renal impairment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Subjects with moderate renal impairment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Subjects with severe renal impairment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Matched healthy subject group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BAY1101042</intervention_name>
    <description>Single oral dose of 10 mg BAY 1101042 (given as 5 mg MR tablets)</description>
    <arm_group_label>Matched healthy subject group</arm_group_label>
    <arm_group_label>Subjects with mild renal impairment</arm_group_label>
    <arm_group_label>Subjects with moderate renal impairment</arm_group_label>
    <arm_group_label>Subjects with severe renal impairment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ability to understand and follow study-related instructions and ability to participate&#xD;
             in the study for the entire period.&#xD;
&#xD;
          -  Age: 18 to 79 years (inclusive) at the screening visit.&#xD;
&#xD;
          -  Body mass index (BMI): 18 to 34 kg/m² (both inclusive).&#xD;
&#xD;
          -  Male or female subject.&#xD;
&#xD;
          -  Only women without childbearing potential will be included in the study (e.g.&#xD;
             postmenopausal for at least one year, women with bilateral ovariectomy and women with&#xD;
             hysterectomy).&#xD;
&#xD;
        Subjects with renal impairment:&#xD;
&#xD;
          -  eGFR &lt;90 mL/min/1.73 m*2 determined from serum creatinine 2-10 days prior to dosing.&#xD;
&#xD;
          -  Stable renal disease, i.e. a serum creatinine value determined at least 3 months&#xD;
             before the pre-study visit (e.g. during routine diagnostics) should not vary by more&#xD;
             than 20% from the serum creatinine value determined at the pre-study visit.&#xD;
&#xD;
        Healthy subjects:&#xD;
&#xD;
        - eGFR ≥90 mL/min/1.73 m*2 determined from serum creatinine 2-10 days prior to dosing.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or lactating women.&#xD;
&#xD;
          -  Medical disorder, condition or history of such that would impair the subject's ability&#xD;
             to participate or complete this study in the opinion of the investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bayer Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Bayer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CRS Clinical-Research-Services Kiel GmbH</name>
      <address>
        <city>Kiel</city>
        <state>Schleswig-Holstein</state>
        <zip>24105</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>July 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>June 2, 2023</last_update_submitted>
  <last_update_submitted_qc>June 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Renal Insufficiency</mesh_term>
  </condition_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/NCT03235076
org study id: 18745
secondary id: 2017-001141-28
nct id: NCT03235076
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To investigate the pharmacokinetics of BAY1101042 in subjects with mild to severe renal
      impairment, stratified according to estimated glomerular filtration rate (eGFR) determined
      2-10 days prior to dosing, and age-, weight- and gender- matched healthy subjects and to
      assess the safety, tolerability, and pharmacodynamics of BAY1101042 after a single oral dose
      of a 10 mg BAY1101042 given as 5 mg modified release (MR) tablet.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Area under the concentration vs. time curve from zero to infinity after single dose (AUC) of BAY1101042
time frame: Study Day 1 to Study Day 6
description: Area under the concentration vs. time curve from zero to infinity after single dose of BAY1101042
measure: Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of BAY1101042
time frame: Study Day 1 to Study Day 6
description: Maximum observed concentration of BAY1101042 in plasma after single dose administration
measure: AUCu of BAY1101042
time frame: Study Day 1 to Study Day 6
description: Area under the unbound concentration vs. time curve from zero to infinity after single dose of BAY1101042
measure: Cmax,u of BAY1101042
time frame: Study Day 1 to Study Day 6
description: Maximum observed unbound concentration of BAY1101042 in plasma after single dose administration of BAY1101042
arm group label: Subjects with mild renal impairment
arm group type: Experimental
description: Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets)
arm group label: Subjects with moderate renal impairment
arm group type: Experimental
description: Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets)
arm group label: Subjects with severe renal impairment
arm group type: Experimental
description: Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets)
arm group label: Matched healthy subject group
arm group type: Experimental
description: Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets)
intervention type: Drug
intervention name: BAY1101042
description: Single oral dose of 10 mg BAY 1101042 (given as 5 mg MR tablets)
arm group label: Matched healthy subject group
arm group label: Subjects with mild renal impairment
arm group label: Subjects with moderate renal impairment
arm group label: Subjects with severe renal impairment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 79 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Bayer Study Director
role: Study Director
affiliation: Bayer
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Renal Insufficiency