<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/NCT03244462</url>
  </required_header>
  <id_info>
    <org_study_id>18387</org_study_id>
    <secondary_id>2016-004393-18</secondary_id>
    <nct_id>NCT03244462</nct_id>
  </id_info>
  <brief_title>Food Effect, Oral &amp; Intravenous Pharmacokinetics and Absolute Bioavailability of BAY1834845 Including Drug-drug Interaction With Methotrexate</brief_title>
  <official_title>Open Label, Randomized, Cross-over Study to Explore the Pharmacokinetics of BAY1834845 After Oral and Intravenous Dosing, Including Food Effect and Absolute Bioavailability (Part A), and to Investigate the Effect of BAY1834845 on the Pharmacokinetics of Orally Administered Methotrexate (Part B) in Healthy Male Subjects</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>
      This study is planned to explore the effect of food on the oral pharmacokinetics, the&#xD;
      intravenous pharmacokinetics and the absolute bioavailability of BAY1834845. Furthermore,&#xD;
      this study will investigate the effect of BAY1834845 on the pharmacokinetics of orally&#xD;
      administered methotrexate in healthy male subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 18, 2017</start_date>
  <completion_date type="Actual">July 20, 2018</completion_date>
  <primary_completion_date type="Actual">January 22, 2018</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>AUC (Area under the concentration-versus-time curve from zero to infinity after single (first) dose) of BAY1834845 after oral administration of BAY1834845 to subjects in fed/fasted state</measure>
    <time_frame>Multiple timepoints up to day 7</time_frame>
    <description>in study part A</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum concentration attained (Cmax) of BAY1834845 after oral administration of BAY1834845 to subjects in fed/fasted state</measure>
    <time_frame>Multiple timepoints up to day 7</time_frame>
    <description>in study part A</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total body clearance (CL) of [13C6] BAY1834845 after intravenous administration</measure>
    <time_frame>Multiple timepoints up to day 7</time_frame>
    <description>in study part A</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Volume of distribution at steady state (Vss) of [13C6] BAY1834845 after intravenous administration</measure>
    <time_frame>Multiple timepoints up to day 7</time_frame>
    <description>in study part A</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Absolute oral bioavailability (F) of BAY1834845 in the fasted state</measure>
    <time_frame>Multiple timepoints up to day 7</time_frame>
    <description>in study part A</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC of methotrexate in plasma in presence/absence of BAY1834845</measure>
    <time_frame>Multiple timepoints up to day 2</time_frame>
    <description>in study part B</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax of methotrexate in plasma in presence/absence of BAY1834845</measure>
    <time_frame>Multiple timepoints up to day 2</time_frame>
    <description>in study part B</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frequency of Treatment Emergent Adverse Events (TEAEs) in part A</measure>
    <time_frame>Up to 9 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of TEAEs in part A</measure>
    <time_frame>Up to 9 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of TEAEs in part B</measure>
    <time_frame>Up to 6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of TEAEs in part B</measure>
    <time_frame>Up to 6 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Inflammation</condition>
  <arm_group>
    <arm_group_label>Oral BAY1834845</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Study Part A, cross over sequence:&#xD;
single oral dose of BAY1834845&#xD;
single oral dose of BAY1834845 + i.v. BAY1834845&#xD;
single oral dose of BAY1834845 under fed conditions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oral BAY1834845 + i.v. BAY1834845</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Study Part A, cross over sequence:&#xD;
single oral dose of BAY1834845+ i.v. BAY1834845&#xD;
single oral dose of BAY1834845&#xD;
single oral dose of BAY1834845 under fed conditions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oral Methotrexate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Study part B, cross over sequence:&#xD;
single oral dose of methotrexate (MTX)&#xD;
single oral dose of MTX + single oral dose of BAY1834845</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oral Methotrexate + oral BAY1834845</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Study part B, cross over sequence:&#xD;
single oral dose of methotrexate (MTX) + single oral dose of BAY1834845&#xD;
single oral dose of MTX</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BAY1834845</intervention_name>
    <description>Single oral dose (IR [immediate release] tablets)</description>
    <arm_group_label>Oral BAY1834845</arm_group_label>
    <arm_group_label>Oral BAY1834845 + i.v. BAY1834845</arm_group_label>
    <arm_group_label>Oral Methotrexate</arm_group_label>
    <arm_group_label>Oral Methotrexate + oral BAY1834845</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BAY1834845</intervention_name>
    <description>I.v. infusion of [13C6]-labeled BAY1834845</description>
    <arm_group_label>Oral BAY1834845</arm_group_label>
    <arm_group_label>Oral BAY1834845 + i.v. BAY1834845</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Methotrexate</intervention_name>
    <description>Single dose of commercially available MTX</description>
    <arm_group_label>Oral Methotrexate</arm_group_label>
    <arm_group_label>Oral Methotrexate + oral BAY1834845</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male; healthy according to complete medical history, physical examination, vital&#xD;
             signs, 12-lead ECG and clinical laboratory tests as listed in the exclusion criteria&#xD;
             given below.&#xD;
&#xD;
          -  Age 18-50 years (inclusive) at the first screening visit.&#xD;
&#xD;
          -  Body mass index: &gt;=18 kg/m² and &lt;=30 kg/m².&#xD;
&#xD;
          -  Sexually active men must agree to practice adequate methods of contraception&#xD;
             (protection).&#xD;
&#xD;
        This applies for the time period between signing of the informed consent form and up to 90&#xD;
        days after the last administration of the study drug(s).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any contraindications for intake of BAY 1834845 or methotrexate, gastrointestinal,&#xD;
             liver, renal, lung or cardiovascular disorders, malignant tumors, known severe&#xD;
             allergies, known or suspected immunodeficiency&#xD;
&#xD;
          -  Medication history: drugs known to induce/inhibit liver enzymes&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  Clinically relevant findings in&#xD;
&#xD;
               -  physical&#xD;
&#xD;
               -  ECG, blood pressure&#xD;
&#xD;
               -  laboratory values&#xD;
&#xD;
          -  Known hypersensitivity to study drug(s)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 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>PRAHealthSciences</name>
      <address>
        <city>Groningen</city>
        <zip>9728 NZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <link>
    <url>https://clinicaltrials.bayer.com/</url>
    <description>Click here to find results for studies related to Bayer products.</description>
  </link>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>July 12, 2019</last_update_submitted>
  <last_update_submitted_qc>July 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 2019</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>Inflammation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Methotrexate</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/NCT03244462
org study id: 18387
secondary id: 2016-004393-18
nct id: NCT03244462
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is planned to explore the effect of food on the oral pharmacokinetics, the
      intravenous pharmacokinetics and the absolute bioavailability of BAY1834845. Furthermore,
      this study will investigate the effect of BAY1834845 on the pharmacokinetics of orally
      administered methotrexate in healthy male subjects.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: AUC (Area under the concentration-versus-time curve from zero to infinity after single (first) dose) of BAY1834845 after oral administration of BAY1834845 to subjects in fed/fasted state
time frame: Multiple timepoints up to day 7
description: in study part A
measure: Maximum concentration attained (Cmax) of BAY1834845 after oral administration of BAY1834845 to subjects in fed/fasted state
time frame: Multiple timepoints up to day 7
description: in study part A
measure: Total body clearance (CL) of [13C6] BAY1834845 after intravenous administration
time frame: Multiple timepoints up to day 7
description: in study part A
measure: Volume of distribution at steady state (Vss) of [13C6] BAY1834845 after intravenous administration
time frame: Multiple timepoints up to day 7
description: in study part A
measure: Absolute oral bioavailability (F) of BAY1834845 in the fasted state
time frame: Multiple timepoints up to day 7
description: in study part A
measure: AUC of methotrexate in plasma in presence/absence of BAY1834845
time frame: Multiple timepoints up to day 2
description: in study part B
measure: Cmax of methotrexate in plasma in presence/absence of BAY1834845
time frame: Multiple timepoints up to day 2
description: in study part B
measure: Frequency of Treatment Emergent Adverse Events (TEAEs) in part A
time frame: Up to 9 weeks
measure: Severity of TEAEs in part A
time frame: Up to 9 weeks
measure: Frequency of TEAEs in part B
time frame: Up to 6 weeks
measure: Severity of TEAEs in part B
time frame: Up to 6 weeks
arm group label: Oral BAY1834845
arm group type: Experimental
description: Study Part A, cross over sequence:
single oral dose of BAY1834845
single oral dose of BAY1834845 + i.v. BAY1834845
single oral dose of BAY1834845 under fed conditions
arm group label: Oral BAY1834845 + i.v. BAY1834845
arm group type: Experimental
description: Study Part A, cross over sequence:
single oral dose of BAY1834845+ i.v. BAY1834845
single oral dose of BAY1834845
single oral dose of BAY1834845 under fed conditions
arm group label: Oral Methotrexate
arm group type: Experimental
description: Study part B, cross over sequence:
single oral dose of methotrexate (MTX)
single oral dose of MTX + single oral dose of BAY1834845
arm group label: Oral Methotrexate + oral BAY1834845
arm group type: Experimental
description: Study part B, cross over sequence:
single oral dose of methotrexate (MTX) + single oral dose of BAY1834845
single oral dose of MTX
intervention type: Drug
intervention name: BAY1834845
description: Single oral dose (IR [immediate release] tablets)
arm group label: Oral BAY1834845
arm group label: Oral BAY1834845 + i.v. BAY1834845
arm group label: Oral Methotrexate
arm group label: Oral Methotrexate + oral BAY1834845
intervention type: Drug
intervention name: BAY1834845
description: I.v. infusion of [13C6]-labeled BAY1834845
arm group label: Oral BAY1834845
arm group label: Oral BAY1834845 + i.v. BAY1834845
intervention type: Drug
intervention name: Methotrexate
description: Single dose of commercially available MTX
arm group label: Oral Methotrexate
arm group label: Oral Methotrexate + oral BAY1834845
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Bayer Study Director
role: Study Director
affiliation: Bayer
facility: 
country: Netherlands
url: https://clinicaltrials.bayer.com/
description: Click here to find results for studies related to Bayer products.
responsible party type: Sponsor
mesh term: Inflammation
mesh term: Methotrexate