<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/NCT01687920</url>
  </required_header>
  <id_info>
    <org_study_id>15481</org_study_id>
    <secondary_id>2012-003055-10</secondary_id>
    <nct_id>NCT01687920</nct_id>
  </id_info>
  <brief_title>Dose Proportionality Study With BAY94-8862 IR (Immediate Release) Tablets</brief_title>
  <official_title>Single Center, Randomized, Open-label, 5-fold Crossover Study in Healthy Male Subjects to Investigate the Pharmacokinetic Dose Proportionality of BAY94-8862 Given as 5 Different Single Oral IR Tablet Doses (1.25, 2.5, 5.0, 7.5 and 10 mg)</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study should estimate the dose proportionality of BAY94-8862 IR tablets.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 17, 2012</start_date>
  <completion_date type="Actual">March 21, 2013</completion_date>
  <primary_completion_date type="Actual">November 28, 2012</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>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dose proportionality of BAY94-8862 exposure in plasma when given as 1.25, 2.5, 5.0, 7.5 and 10 mg IR tablets</measure>
    <time_frame>0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 28 &amp; 48 h</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events as a measure of safety and tolerability of BAY94-8862</measure>
    <time_frame>Up to 48 h</time_frame>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>BAY94-8862 (1.25mg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>single dose BAY94-8862 IR tablet 1.25mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BAY94-8862 (2.5mg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>single dose BAY94-8862 IR tablet 2.5mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BAY94-8862 (5mg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>single dose BAY94-8862 IR tablet 5mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BAY94-8862 (7.5mg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>single dose BAY94-8862 IR tablet 7.5mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BAY94-8862 (10mg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>single dose BAY94-8862 IR tablet 10mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BAY94-8862 (1.25mg)</intervention_name>
    <arm_group_label>BAY94-8862 (1.25mg)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BAY94-8862 (2.5mg)</intervention_name>
    <arm_group_label>BAY94-8862 (2.5mg)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BAY94-8862 (5mg)</intervention_name>
    <arm_group_label>BAY94-8862 (5mg)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BAY94-8862 (7.5mg)</intervention_name>
    <arm_group_label>BAY94-8862 (7.5mg)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BAY94-8862 (10mg)</intervention_name>
    <arm_group_label>BAY94-8862 (10mg)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male subject&#xD;
&#xD;
          -  Age: 18 to 46 years (inclusive) at the first screening examination&#xD;
&#xD;
          -  Ethnicity: White&#xD;
&#xD;
          -  Body mass index (BMI): &gt;= 18 and &lt;= 29.9 kg / m²&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinically relevant findings in the ECG (electrocardiogram) such as a second- or&#xD;
             third-degree AV block, prolongation of the QRS complex over 120 msec&#xD;
&#xD;
          -  Systolic blood pressure below 100 or above 140 mmHg&#xD;
&#xD;
          -  Diastolic blood pressure below 50 or above 90 mmHg&#xD;
&#xD;
          -  Heart rate below 50 or above 95 beats/ min&#xD;
&#xD;
          -  Positive results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus&#xD;
             antibodies (anti-HCV), human immune deficiency virus antibodies (anti-HIV 1+2)&#xD;
&#xD;
          -  Participation in another clinical study during the preceding 3 months (Last Treatment&#xD;
             from previous study to First Treatment of new study)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>46 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_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>http://clinicaltrials.bayer.com/</url>
    <description>Click here to find results for studies related to Bayer products</description>
  </link>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>September 14, 2012</study_first_submitted>
  <study_first_submitted_qc>September 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <last_update_submitted>January 27, 2022</last_update_submitted>
  <last_update_submitted_qc>January 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cardiac disorders</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</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/NCT01687920
org study id: 15481
secondary id: 2012-003055-10
nct id: NCT01687920
lead sponsor: 
has dmc: No
This study should estimate the dose proportionality of BAY94-8862 IR tablets.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: Dose proportionality of BAY94-8862 exposure in plasma when given as 1.25, 2.5, 5.0, 7.5 and 10 mg IR tablets
time frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 28 & 48 h
measure: Number of participants with adverse events as a measure of safety and tolerability of BAY94-8862
time frame: Up to 48 h
arm group label: BAY94-8862 (1.25mg)
arm group type: Experimental
description: single dose BAY94-8862 IR tablet 1.25mg
arm group label: BAY94-8862 (2.5mg)
arm group type: Experimental
description: single dose BAY94-8862 IR tablet 2.5mg
arm group label: BAY94-8862 (5mg)
arm group type: Experimental
description: single dose BAY94-8862 IR tablet 5mg
arm group label: BAY94-8862 (7.5mg)
arm group type: Experimental
description: single dose BAY94-8862 IR tablet 7.5mg
arm group label: BAY94-8862 (10mg)
arm group type: Experimental
description: single dose BAY94-8862 IR tablet 10mg
intervention type: Drug
intervention name: BAY94-8862 (1.25mg)
arm group label: BAY94-8862 (1.25mg)
intervention type: Drug
intervention name: BAY94-8862 (2.5mg)
arm group label: BAY94-8862 (2.5mg)
intervention type: Drug
intervention name: BAY94-8862 (5mg)
arm group label: BAY94-8862 (5mg)
intervention type: Drug
intervention name: BAY94-8862 (7.5mg)
arm group label: BAY94-8862 (7.5mg)
intervention type: Drug
intervention name: BAY94-8862 (10mg)
arm group label: BAY94-8862 (10mg)
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 46 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Bayer Study Director
role: Study Director
affiliation: Bayer
facility: 
country: Germany
url: http://clinicaltrials.bayer.com/
description: Click here to find results for studies related to Bayer products
responsible party type: Sponsor
mesh term: Heart Failure