<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/NCT02212080</url>
  </required_header>
  <id_info>
    <org_study_id>16924</org_study_id>
    <secondary_id>2014-000412-34</secondary_id>
    <nct_id>NCT02212080</nct_id>
  </id_info>
  <brief_title>First in Human Study in Healthy Volunteers to Investigate the Safety, Tolerability and Pharmacokinetics of BAY1214784</brief_title>
  <official_title>One-center, Randomized, Placebo-controlled, Double Blind, Parallel Group Study to Investigate the Safety, Tolerability and Pharmacokinetics of Increasing Single Oral Doses (5-1000 mg, Solution) of BAY1214784 Including the Relative Bioavailability of BAY1214784 Administered as Solution With Two Different Concentrations in 56 Healthy Postmenopausal Women</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 is a first in human study that will investigate the safety, tolerability and&#xD;
      pharmacokinetics of ascending single doses of BAY1214784 using a placebo controlled,&#xD;
      randomized, single center design. In addition the bioavailability of two different liquid&#xD;
      formulations will be compared.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</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>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of adverse events</measure>
    <time_frame>Up to 2 weeks after dosing</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Severity of adverse events (mild, moderate, severe)</measure>
    <time_frame>Up to 2 weeks after dosing</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Clinical Trials, Phase I as Topic</condition>
  <arm_group>
    <arm_group_label>BAY1214784</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dose 1 to 7 of BAY1214784</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo Dose 1 to 7 of BAY1214784</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BAY1214784</intervention_name>
    <description>Escalating doses of 5, 20, 60, 150, 300, 600, 1000 mg of BAY1214784; single dose administration; liquid dosage form</description>
    <arm_group_label>BAY1214784</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Dose 1, 2,3, 4, 5, 6 and 7 of respective placebos; single dose administration; liquid dosage form</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy female subjects&#xD;
&#xD;
          -  Age 45 to 65 years&#xD;
&#xD;
          -  Body mass index (BMI) above/equal 20 and below/equal 30 kg/m2&#xD;
&#xD;
          -  Postmenopausal state&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Incompletely cured pre-existing diseases for which it can be assumed that the&#xD;
             absorption, distribution, metabolism, elimination and effects of the study drugs will&#xD;
             not be normal&#xD;
&#xD;
          -  Known or suspected malignant or benign tumors&#xD;
&#xD;
          -  Known or suspected liver disorders, relevant kidney diseases, known cardiovascular&#xD;
             diseases, known metabolic disorders&#xD;
&#xD;
          -  Regular use of medicines&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>65 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>
      <address>
        <city>Mönchengladbach</city>
        <state>Nordrhein-Westfalen</state>
        <zip>41061</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Erfurt</city>
        <state>Thüringen</state>
        <zip>99084</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2014</study_first_posted>
  <last_update_submitted>March 10, 2015</last_update_submitted>
  <last_update_submitted_qc>March 10, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 11, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02212080
org study id: 16924
secondary id: 2014-000412-34
nct id: NCT02212080
lead sponsor: 
has dmc: No
This study is a first in human study that will investigate the safety, tolerability and
      pharmacokinetics of ascending single doses of BAY1214784 using a placebo controlled,
      randomized, single center design. In addition the bioavailability of two different liquid
      formulations will be compared.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of adverse events
time frame: Up to 2 weeks after dosing
measure: Severity of adverse events (mild, moderate, severe)
time frame: Up to 2 weeks after dosing
arm group label: BAY1214784
arm group type: Experimental
description: Dose 1 to 7 of BAY1214784
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo Dose 1 to 7 of BAY1214784
intervention type: Drug
intervention name: BAY1214784
description: Escalating doses of 5, 20, 60, 150, 300, 600, 1000 mg of BAY1214784; single dose administration; liquid dosage form
arm group label: BAY1214784
intervention type: Drug
intervention name: Placebo
description: Dose 1, 2,3, 4, 5, 6 and 7 of respective placebos; single dose administration; liquid dosage form
arm group label: Placebo
criteria: 
gender: Female
minimum age: 45 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Bayer Study Director
role: Study Director
affiliation: Bayer
facility: 
facility: 
country: Germany
responsible party type: Sponsor