<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/NCT03252002</url>
  </required_header>
  <id_info>
    <org_study_id>18747</org_study_id>
    <secondary_id>2017-001212-11</secondary_id>
    <nct_id>NCT03252002</nct_id>
  </id_info>
  <brief_title>Clinical Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Pharmacodynamic Effects of a Single and Multiple Oral BAY1101042 Tablet Doses in Healthy Male Subjects</brief_title>
  <official_title>Single/Multiple Dose Escalation Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BAY1101042 Given as 5 mg MR Tablet After Single Oral Dosing Followed by Once Daily Dosing for 7 Days in 12 Healthy Male Subjects Per Dose Step in a Randomized, Placebo Controlled, Single Blind, Group Comparison 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 safety, tolerability, pharmacokinetics and effects of BAY1101042 in&#xD;
      healthy male subjects after a single oral dose and multiple once daily dosing for 7 days&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 16, 2017</start_date>
  <completion_date type="Actual">July 24, 2019</completion_date>
  <primary_completion_date type="Actual">April 30, 2019</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>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of treatment emergent adverse events (TEAEs)</measure>
    <time_frame>Approximately 19 days</time_frame>
    <description>Assessment of treatment emergent adverse events from first study drug intake until follow up</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>AUC(0-24) of BAY1101042</measure>
    <time_frame>At day 1</time_frame>
    <description>AUC(0-24): area under the concentration vs. time curve from zero to 24 hours after single dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC(0-24)/D of BAY1101042</measure>
    <time_frame>At day 1</time_frame>
    <description>AUC(0-24)/D: dose-normalized area under the concentration vs. time curve from zero to 24 hours after single dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax of BAY1101042</measure>
    <time_frame>At day 1</time_frame>
    <description>Cmax: maximum observed drug concentration after single dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax/D of BAY1101042</measure>
    <time_frame>At day 1</time_frame>
    <description>Cmax/D: dose-normalized maximum observed drug concentration after single dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUCτ,md of BAY1101042</measure>
    <time_frame>At day 9</time_frame>
    <description>AUCτ,md: area under the concentration vs. time curve for the actual dosing interval after multiple dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUCτ,md/D of BAY1101042</measure>
    <time_frame>At day 9</time_frame>
    <description>AUCτ,md/D: dose-normalized area under the concentration vs. time curve for the actual dosing interval after multiple dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax,md of BAY1101042</measure>
    <time_frame>At day 9</time_frame>
    <description>Cmax,md: maximum observed drug concentration after multiple dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax,md/D of BAY1101042</measure>
    <time_frame>At day 9</time_frame>
    <description>Cmax,md/D: dose-normalized maximum observed drug concentration after multiple dose</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">96</enrollment>
  <condition>Healthy Volunteer</condition>
  <arm_group>
    <arm_group_label>Single/multiple doses of 10 mg BAY1101042 or placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Single/ multiple doses of 20 mg BAY1101042 or placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single oral dose of 20 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Single/ multiple doses of 30 mg BAY1101042 or placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single oral dose of 30 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Single/ multiple doses of 40 mg BAY1101042 or placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single oral dose of 40 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Single/ multiple doses of 50 mg BAY1101042 or placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single oral dose of 50 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Optional: Single/multiple doses of 5 mg BAY 1101042 or placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single oral dose of 5 mg BAY1101042 MR tablets or corresponding placebo followed by once daily dosing for 7 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BAY1101042</intervention_name>
    <description>Single oral dose of 10 mg, 20 mg, 30 mg, 40 mg, 50 mg or optionally 5 mg BAY 1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days</description>
    <arm_group_label>Optional: Single/multiple doses of 5 mg BAY 1101042 or placebo</arm_group_label>
    <arm_group_label>Single/ multiple doses of 20 mg BAY1101042 or placebo</arm_group_label>
    <arm_group_label>Single/ multiple doses of 30 mg BAY1101042 or placebo</arm_group_label>
    <arm_group_label>Single/ multiple doses of 40 mg BAY1101042 or placebo</arm_group_label>
    <arm_group_label>Single/ multiple doses of 50 mg BAY1101042 or placebo</arm_group_label>
    <arm_group_label>Single/multiple doses of 10 mg BAY1101042 or placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Single dose on Day 1 (00d) and once daily for 7 days from Day 3 (02d) until Day 9 (08d)</description>
    <arm_group_label>Optional: Single/multiple doses of 5 mg BAY 1101042 or placebo</arm_group_label>
    <arm_group_label>Single/ multiple doses of 20 mg BAY1101042 or placebo</arm_group_label>
    <arm_group_label>Single/ multiple doses of 30 mg BAY1101042 or placebo</arm_group_label>
    <arm_group_label>Single/ multiple doses of 40 mg BAY1101042 or placebo</arm_group_label>
    <arm_group_label>Single/ multiple doses of 50 mg BAY1101042 or placebo</arm_group_label>
    <arm_group_label>Single/multiple doses of 10 mg BAY1101042 or placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The informed consent must be signed before any study specific tests or procedures are&#xD;
             done.&#xD;
&#xD;
          -  Healthy male subject.&#xD;
&#xD;
          -  Age: 18 to 45 years (inclusive) at the screening.&#xD;
&#xD;
          -  Body mass index (BMI): above/equal 18 and below/equal 29.9 kg/m2.&#xD;
&#xD;
          -  Ability to understand and follow study-related instructions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pre-existing diseases for which it can be assumed that the absorption, distribution,&#xD;
             metabolism, elimination and effects of the study drugs will not be normal.&#xD;
&#xD;
          -  Subjects with thyroid disorders as evidenced by assessment of thyroid stimulating&#xD;
             hormone (TSH) levels outside the normal reference range at screening.&#xD;
&#xD;
          -  Regular use of medicines.&#xD;
&#xD;
          -  Smoking more than 10 cigarettes daily.&#xD;
&#xD;
          -  Systolic blood pressure below 100 or above 145 mmHg (at screening).&#xD;
&#xD;
          -  Diastolic blood pressure below 50 or above 90 mmHg (at screening).&#xD;
&#xD;
          -  Heart rate below 50 or above 90 beats/ min (at screening).&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 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 Mönchengladbach GmbH</name>
      <address>
        <city>Mönchengladbach</city>
        <state>Nordrhein-Westfalen</state>
        <zip>41061</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CRS Clinical Research Services Wuppertal GmbH</name>
      <address>
        <city>Wuppertal</city>
        <state>Nordrhein-Westfalen</state>
        <zip>42113</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>August 4, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>August 16, 2019</last_update_submitted>
  <last_update_submitted_qc>August 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic kidney disease</keyword>
  <!-- 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/NCT03252002
org study id: 18747
secondary id: 2017-001212-11
nct id: NCT03252002
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To investigate the safety, tolerability, pharmacokinetics and effects of BAY1101042 in
      healthy male subjects after a single oral dose and multiple once daily dosing for 7 days
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
measure: Number of treatment emergent adverse events (TEAEs)
time frame: Approximately 19 days
description: Assessment of treatment emergent adverse events from first study drug intake until follow up
measure: AUC(0-24) of BAY1101042
time frame: At day 1
description: AUC(0-24): area under the concentration vs. time curve from zero to 24 hours after single dose
measure: AUC(0-24)/D of BAY1101042
time frame: At day 1
description: AUC(0-24)/D: dose-normalized area under the concentration vs. time curve from zero to 24 hours after single dose
measure: Cmax of BAY1101042
time frame: At day 1
description: Cmax: maximum observed drug concentration after single dose
measure: Cmax/D of BAY1101042
time frame: At day 1
description: Cmax/D: dose-normalized maximum observed drug concentration after single dose
measure: AUCτ,md of BAY1101042
time frame: At day 9
description: AUCτ,md: area under the concentration vs. time curve for the actual dosing interval after multiple dose
measure: AUCτ,md/D of BAY1101042
time frame: At day 9
description: AUCτ,md/D: dose-normalized area under the concentration vs. time curve for the actual dosing interval after multiple dose
measure: Cmax,md of BAY1101042
time frame: At day 9
description: Cmax,md: maximum observed drug concentration after multiple dose
measure: Cmax,md/D of BAY1101042
time frame: At day 9
description: Cmax,md/D: dose-normalized maximum observed drug concentration after multiple dose
arm group label: Single/multiple doses of 10 mg BAY1101042 or placebo
arm group type: Experimental
description: Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days
arm group label: Single/ multiple doses of 20 mg BAY1101042 or placebo
arm group type: Experimental
description: Single oral dose of 20 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days
arm group label: Single/ multiple doses of 30 mg BAY1101042 or placebo
arm group type: Experimental
description: Single oral dose of 30 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days
arm group label: Single/ multiple doses of 40 mg BAY1101042 or placebo
arm group type: Experimental
description: Single oral dose of 40 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days
arm group label: Single/ multiple doses of 50 mg BAY1101042 or placebo
arm group type: Experimental
description: Single oral dose of 50 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days
arm group label: Optional: Single/multiple doses of 5 mg BAY 1101042 or placebo
arm group type: Experimental
description: Single oral dose of 5 mg BAY1101042 MR tablets or corresponding placebo followed by once daily dosing for 7 days
intervention type: Drug
intervention name: BAY1101042
description: Single oral dose of 10 mg, 20 mg, 30 mg, 40 mg, 50 mg or optionally 5 mg BAY 1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days
arm group label: Optional: Single/multiple doses of 5 mg BAY 1101042 or placebo
arm group label: Single/ multiple doses of 20 mg BAY1101042 or placebo
arm group label: Single/ multiple doses of 30 mg BAY1101042 or placebo
arm group label: Single/ multiple doses of 40 mg BAY1101042 or placebo
arm group label: Single/ multiple doses of 50 mg BAY1101042 or placebo
arm group label: Single/multiple doses of 10 mg BAY1101042 or placebo
intervention type: Drug
intervention name: Placebo
description: Single dose on Day 1 (00d) and once daily for 7 days from Day 3 (02d) until Day 9 (08d)
arm group label: Optional: Single/multiple doses of 5 mg BAY 1101042 or placebo
arm group label: Single/ multiple doses of 20 mg BAY1101042 or placebo
arm group label: Single/ multiple doses of 30 mg BAY1101042 or placebo
arm group label: Single/ multiple doses of 40 mg BAY1101042 or placebo
arm group label: Single/ multiple doses of 50 mg BAY1101042 or placebo
arm group label: Single/multiple doses of 10 mg BAY1101042 or placebo
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Bayer Study Director
role: Study Director
affiliation: Bayer
facility: 
facility: 
country: Germany
responsible party type: Sponsor