<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/NCT04447261</url>
  </required_header>
  <id_info>
    <org_study_id>1427-0002</org_study_id>
    <secondary_id>2020-000342-34</secondary_id>
    <nct_id>NCT04447261</nct_id>
  </id_info>
  <brief_title>A Study to Test How Well Different Doses of BI 1356225 Are Tolerated by Men and Women With Obesity or Overweight</brief_title>
  <official_title>Safety, Tolerability, and Pharmacokinetics of Multiple Rising Oral Doses of BI 1356225 (Randomised, Placebo-controlled, Blinded Within Dose Groups) and Evaluation of Midazolam and Celecoxib Interaction (Nested, Open, Fixed-sequence, Intra-individual Comparison) in Patients With Overweight or Obesity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this trial is to investigate safety and tolerability of BI 1356225&#xD;
      in male and female patients with overweight and obesity following oral administration of&#xD;
      multiple rising doses per day over 28 days. Secondary objectives are the exploration of&#xD;
      pharmacokinetics (PK) of BI 1356225 after multiple oral dosing. Additionally, the relative&#xD;
      bioavailability (BA) of midazolam and celecoxib in the presence and absence of BI 1356225&#xD;
      will be evaluated&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 30, 2020</start_date>
  <completion_date type="Actual">April 25, 2021</completion_date>
  <primary_completion_date type="Actual">April 25, 2021</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>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The percentage of subjects with drug-related adverse events</measure>
    <time_frame>Up to 40 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>AUCτ, 1 (area under the concentration-time curve of BI 1356225 in plasma over a uniform dosing interval τ after administration of the first dose)</measure>
    <time_frame>Up to 35 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax,1 (maximum measured concentration of BI 1356225 in plasma after administration of the first dose)</measure>
    <time_frame>Up to 35 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUCτ,ss (area under the concentration-time curve of BI 1356225 in plasma at steady state over a uniform dosing interval τ after administration of the last dose)</measure>
    <time_frame>Up to 35 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax,ss (maximum measured concentration of BI 1356225 in plasma at steady state over a uniform dosing interval τ after administration of the last dose)</measure>
    <time_frame>Up to 35 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-tz (area under the concentration-time curve of midazolam in plasma over the time interval from 0 to the last quantifiable data point)</measure>
    <time_frame>Up to 35 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-tz (area under the concentration-time curve of celecoxib in plasma over the time interval from 0 to the last quantifiable data point)</measure>
    <time_frame>Up to 35 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax (maximum measured concentration of midazolam in plasma)</measure>
    <time_frame>Up to 35 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax (maximum measured concentration of celecoxib in plasma)</measure>
    <time_frame>Up to 35 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">87</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>BI 1356225</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 1356225</intervention_name>
    <description>BI 1356225</description>
    <arm_group_label>BI 1356225</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          -  Male and female patients, age ≥ 18 and &lt; 70&#xD;
&#xD;
          -  Body Mass Index ≥ 27 kg/m2 and &lt; 40 kg/m2 at screening&#xD;
&#xD;
          -  Stable body weight (defined as no more than 5% change) within 3 months prior to&#xD;
             screening&#xD;
&#xD;
          -  further inclusion criteria apply&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          -  Females of childbearing potential&#xD;
&#xD;
          -  Clinically relevant concomitant disease per investigator judgment&#xD;
&#xD;
          -  Any condition or disease requiring permanent pharmacotherapy during the trial&#xD;
&#xD;
          -  Any history of lifetime suicidal behaviour and any suicidal ideation of type 2 - 5 in&#xD;
             the Columbia-Suicide Severity Rating Scale (C-SSRS) in the past 12 months&#xD;
&#xD;
          -  further exclusion criteria apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CRS Clinical Research Services Mannheim GmbH</name>
      <address>
        <city>Mannheim</city>
        <zip>68167</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>https://www.mystudywindow.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>May 18, 2021</last_update_submitted>
  <last_update_submitted_qc>May 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 19, 2021</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>Obesity</mesh_term>
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).For more details refer to: http://trials.boehringer-ingelheim.com/</ipd_description>
  </patient_data>
  <!-- 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/NCT04447261
org study id: 1427-0002
secondary id: 2020-000342-34
nct id: NCT04447261
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The primary objective of this trial is to investigate safety and tolerability of BI 1356225
      in male and female patients with overweight and obesity following oral administration of
      multiple rising doses per day over 28 days. Secondary objectives are the exploration of
      pharmacokinetics (PK) of BI 1356225 after multiple oral dosing. Additionally, the relative
      bioavailability (BA) of midazolam and celecoxib in the presence and absence of BI 1356225
      will be evaluated
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: The percentage of subjects with drug-related adverse events
time frame: Up to 40 days
measure: AUCτ, 1 (area under the concentration-time curve of BI 1356225 in plasma over a uniform dosing interval τ after administration of the first dose)
time frame: Up to 35 days
measure: Cmax,1 (maximum measured concentration of BI 1356225 in plasma after administration of the first dose)
time frame: Up to 35 days
measure: AUCτ,ss (area under the concentration-time curve of BI 1356225 in plasma at steady state over a uniform dosing interval τ after administration of the last dose)
time frame: Up to 35 days
measure: Cmax,ss (maximum measured concentration of BI 1356225 in plasma at steady state over a uniform dosing interval τ after administration of the last dose)
time frame: Up to 35 days
measure: AUC0-tz (area under the concentration-time curve of midazolam in plasma over the time interval from 0 to the last quantifiable data point)
time frame: Up to 35 days
measure: AUC0-tz (area under the concentration-time curve of celecoxib in plasma over the time interval from 0 to the last quantifiable data point)
time frame: Up to 35 days
measure: Cmax (maximum measured concentration of midazolam in plasma)
time frame: Up to 35 days
measure: Cmax (maximum measured concentration of celecoxib in plasma)
time frame: Up to 35 days
arm group label: BI 1356225
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: BI 1356225
description: BI 1356225
arm group label: BI 1356225
intervention type: Drug
intervention name: Placebo
description: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: Germany
url: https://www.mystudywindow.com
description: Related Info
responsible party type: Sponsor
mesh term: Obesity
mesh term: Overweight
sharing ipd: No
ipd description: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).For more details refer to: http://trials.boehringer-ingelheim.com/