xml: <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/NCT05985200</url>
    </required_header>
    <id_info>
      <org_study_id>1486-0002</org_study_id>
      <secondary_id>U1111-1289-1904</secondary_id>
      <secondary_id>2023-503332-40-00</secondary_id>
      <nct_id>NCT05985200</nct_id>
    </id_info>
    <brief_title>A Study in Healthy People to Test How Well Repeated Doses of BI 3032950 Are Tolerated</brief_title>
    <official_title>Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Rising Intravenous Doses of BI 3032950 in Healthy Male and Female Subjects (Single-blind, Randomised Within Dose Groups, Placebo-controlled Parallel-group Design)</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>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The main objectives of this trial are to investigate safety, tolerability, pharmacokinetics&#xD;
        and pharmacodynamics following multiple rising intravenous doses of BI 3032950 in healthy&#xD;
        male subjects and postmenopausal or surgically sterilised female subjects (WNOCBP).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 5, 2023</start_date>
    <completion_date type="Anticipated">August 19, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 19, 2024</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>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Occurrence of any treatment-emergent adverse event</measure>
      <time_frame>Up to Day 137</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator</measure>
      <time_frame>Up to Day 137</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area under the concentration-time curve of the analyte in serum over a uniform dosing interval τ (AUCτ,)</measure>
      <time_frame>From Day 22 to Day 134</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maximum measured concentration of the analyte in serum (Cmax)</measure>
      <time_frame>From Day 22 to Day 134</time_frame>
    </secondary_outcome>
    <number_of_arms>5</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Healthy</condition>
    <arm_group>
      <arm_group_label>BI 3032950: Dose group 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>BI 3032950: Dose group 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>BI 3032950: Dose group 3</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>BI 3032950: Dose group 4</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 3032950</intervention_name>
      <description>BI 3032950</description>
      <arm_group_label>BI 3032950: Dose group 1</arm_group_label>
      <arm_group_label>BI 3032950: Dose group 2</arm_group_label>
      <arm_group_label>BI 3032950: Dose group 3</arm_group_label>
      <arm_group_label>BI 3032950: Dose group 4</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo matching BI 3032950</intervention_name>
      <description>Placebo matching BI 3032950</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Healthy male subjects and female subjects not of child bearing potential (WNOCBP) -&#xD;
               postmenopausal or surgically sterilised female subjects according to the assessment of&#xD;
               the investigator, as based on a complete medical history including a physical&#xD;
               examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead&#xD;
               electrocardiogram (ECG), and clinical laboratory tests&#xD;
  &#xD;
            2. Age of 18 to 65 years (inclusive)&#xD;
  &#xD;
            3. Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)&#xD;
  &#xD;
            4. Signed and dated written informed consent in accordance with International conference&#xD;
               on harmonisation-good clinical practice (ICH-GCP) and local legislation prior to&#xD;
               admission to the trial Further inclusion criteria apply.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal&#xD;
               and assessed as clinically relevant by the investigator&#xD;
  &#xD;
            2. Repeated measurement of systolic blood pressure outside the range of 90 to 140&#xD;
               millimetre mercury (mmHg), diastolic blood pressure outside the range of 50 to 90&#xD;
               mmHg, or pulse rate outside the range of 45 to 100 beats per minute (bpm); in case of&#xD;
               documented 'white coat hypertension' the decision for eligibility is left to the&#xD;
               investigator&#xD;
  &#xD;
            3. Any laboratory value outside the reference range that the investigator considers to be&#xD;
               of clinical relevance&#xD;
  &#xD;
            4. Any evidence of a concomitant disease assessed as clinically relevant by the&#xD;
               investigator Further exclusion criteria apply.&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Boehringer Ingelheim</last_name>
      <phone>1-800-243-0127</phone>
      <email>clintriage.rdg@boehringer-ingelheim.com</email>
    </overall_contact>
    <link>
      <url>https://www.mystudywindow.com</url>
      <description>Related Info</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <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. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05985200
  org study id: 1486-0002
  secondary id: U1111-1289-1904
  secondary id: 2023-503332-40-00
  nct id: NCT05985200
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The main objectives of this trial are to investigate safety, tolerability, pharmacokinetics
        and pharmacodynamics following multiple rising intravenous doses of BI 3032950 in healthy
        male subjects and postmenopausal or surgically sterilised female subjects (WNOCBP).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Occurrence of any treatment-emergent adverse event
  time frame: Up to Day 137
  measure: Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator
  time frame: Up to Day 137
  measure: Area under the concentration-time curve of the analyte in serum over a uniform dosing interval τ (AUCτ,)
  time frame: From Day 22 to Day 134
  measure: Maximum measured concentration of the analyte in serum (Cmax)
  time frame: From Day 22 to Day 134
  arm group label: BI 3032950: Dose group 1
  arm group type: Experimental
  arm group label: BI 3032950: Dose group 2
  arm group type: Experimental
  arm group label: BI 3032950: Dose group 3
  arm group type: Experimental
  arm group label: BI 3032950: Dose group 4
  arm group type: Experimental
  arm group label: Placebo
  arm group type: Placebo Comparator
  intervention type: Drug
  intervention name: BI 3032950
  description: BI 3032950
  arm group label: BI 3032950: Dose group 1
  arm group label: BI 3032950: Dose group 2
  arm group label: BI 3032950: Dose group 3
  arm group label: BI 3032950: Dose group 4
  intervention type: Drug
  intervention name: Placebo matching BI 3032950
  description: Placebo matching BI 3032950
  arm group label: Placebo
  criteria: 
  gender: Male
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Boehringer Ingelheim
  phone: 1-800-243-0127
  email: clintriage.rdg@boehringer-ingelheim.com
  url: https://www.mystudywindow.com
  description: Related Info
  responsible party type: Sponsor
  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. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency.