<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/NCT03230487</url>
  </required_header>
  <id_info>
    <org_study_id>1305-0011</org_study_id>
    <secondary_id>2017-002003-10</secondary_id>
    <nct_id>NCT03230487</nct_id>
  </id_info>
  <brief_title>This Study Tests How Healthy Men Tolerate Different Doses of BI1015550. The Study Also Tests How BI 1015550 is Taken up by the Body</brief_title>
  <official_title>Safety, Tolerability, and Pharmacokinetics of Single (Part 1) and Multiple Rising Oral Doses (Part 2) of BI 1015550 in Healthy Male Subjects</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>
      Part 1 (SRD (Single-rising dose)):&#xD;
&#xD;
      The primary objective of this trial part is to investigate the safety and tolerability of BI&#xD;
      1015550 in healthy male subjects following oral administration of single rising doses.&#xD;
&#xD;
      Secondary objectives are the exploration of the pharmacokinetics of BI 1015550 after single&#xD;
      dosing.&#xD;
&#xD;
      Part 2 (MRD (Multiple-rising dose)):&#xD;
&#xD;
      In Part 2, the primary objective is to investigate the safety and tolerability of BI 1015550&#xD;
      in healthy male subjects following oral administration of multiple rising doses.&#xD;
&#xD;
      Secondary objectives are the exploration of the pharmacokinetics of BI 1015550 after multiple&#xD;
      dosing.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 10, 2017</start_date>
  <completion_date type="Actual">January 16, 2018</completion_date>
  <primary_completion_date type="Actual">January 16, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number [N (%)] of subjects with drug-related Adverse Events (AEs)</measure>
    <time_frame>Up to 9 days (Part 1)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number [N (%)] of subjects with drug-related Adverse Events (AEs)</measure>
    <time_frame>Up to 28 days (Part 2)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Part 1 (SRD): AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)</measure>
    <time_frame>up to 120 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 1 (SRD): Cmax (maximum measured concentration of the analyte in plasma)</measure>
    <time_frame>up to 120 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2 (MRD): After the first dose - AUCtau,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval tau after administration of the first dose)</measure>
    <time_frame>up to 48 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2 (MRD): After the first dose - Cmax (maximum measured concentration of the analyte in plasma)</measure>
    <time_frame>up to 48 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2 (MRD): After the last dose - AUCtau,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval tau)</measure>
    <time_frame>up to 504 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2 (MRD): After the last dose - Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval tau)</measure>
    <time_frame>up to 504 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>RA,Cmax (accumulation ratio based on Cmax,ss)</measure>
    <time_frame>up to 504 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>RA,AUC (accumulation ratio based on AUC0-tau)</measure>
    <time_frame>up to 504 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>BI 1015550</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 1015550</intervention_name>
    <description>Part 1 - single rising dose. Part 2 multiple rising dose</description>
    <arm_group_label>BI 1015550</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Part 1 - single rising dose. Part 2 multiple rising dose</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male subjects according to the assessment of the investigator, based on a&#xD;
             complete medical history including a physical examination, vital signs, 12-lead&#xD;
             Electrocardiogram (ECG), and clinical laboratory tests&#xD;
&#xD;
          -  Age of 18 to 45 years (incl.)&#xD;
&#xD;
          -  Body Mass Index (BMI) of 18.5 to 29.9 kg/m2 (incl.)&#xD;
&#xD;
          -  Signed and dated written informed consent prior to admission to the study in&#xD;
             accordance with Good Clinical Practice (GCP) and local legislation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any finding in the medical examination (including vital signs or Electrocardiogram&#xD;
             (ECG)) is deviating from normal and judged as clinically relevant by the investigator&#xD;
&#xD;
          -  Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg,&#xD;
             diastolic blood pressure outside the range of 55 to 90 mmHg, or pulse rate outside the&#xD;
             range of 50 to 90 beats per minute (bpm)&#xD;
&#xD;
          -  Any laboratory value outside the reference range that the investigator considers to be&#xD;
             of clinical relevance&#xD;
&#xD;
          -  Any evidence of a concomitant disease judged as clinically relevant by the&#xD;
             investigator&#xD;
&#xD;
          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological or hormonal disorders&#xD;
&#xD;
          -  Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with&#xD;
             the pharmacokinetics of the trial medication (except appendectomy)&#xD;
&#xD;
          -  Diseases of the central nervous system (including but not limited to any kind of&#xD;
             seizures or stroke), and other relevant neurological or psychiatric disorders,&#xD;
             including but not limited to mood disorders and any history of suicidality.&#xD;
&#xD;
          -  History of relevant orthostatic hypotension, fainting spells, or blackouts&#xD;
&#xD;
          -  Chronic or relevant acute infections&#xD;
&#xD;
          -  History of relevant allergy or hypersensitivity (including allergy to the trial&#xD;
             medication or its excipients)&#xD;
&#xD;
          -  Use of drugs within 30 days prior to administration of trial medication if that might&#xD;
             reasonably influence the results of the trial (incl. QT/QTc interval prolongation)&#xD;
&#xD;
          -  Participation in another trial where an investigational drug has been administered&#xD;
             within 60 days prior to planned administration of trial medication, or current&#xD;
             participation in another trial involving administration of investigational drug&#xD;
&#xD;
          -  Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)&#xD;
&#xD;
          -  Inability to refrain from smoking on trial days&#xD;
&#xD;
          -  Alcohol abuse (consumption of more than 20 g per day)&#xD;
&#xD;
          -  Drug abuse or positive drug screening&#xD;
&#xD;
          -  Blood donation of more than 100 mL within 30 days prior to administration of trial&#xD;
             medication or intended donation during the trial&#xD;
&#xD;
          -  Intention to perform excessive physical activities within one week prior to&#xD;
             administration of trial medication or during the trial&#xD;
&#xD;
          -  Inability to comply with dietary regimen of trial site&#xD;
&#xD;
          -  A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are&#xD;
             repeatedly greater than 450 ms) or any other relevant ECG finding at screening&#xD;
&#xD;
          -  A history of additional risk factors for Torsades de Pointes (such as heart failure,&#xD;
             hypokalemia, or family history of Long QT Syndrome)&#xD;
&#xD;
          -  Subject is assessed as unsuitable for inclusion by the investigator, for instance,&#xD;
             because considered not able to understand and comply with study requirements, or has a&#xD;
             condition that would not allow safe participation in the study&#xD;
&#xD;
          -  Male subjects who do not agree to minimize the risk of female partners becoming&#xD;
             pregnant from the first dosing day until two months after the study completion.&#xD;
             Acceptable methods of contraception comprises barrier contraception and a medically&#xD;
             accepted contraceptive method for the female partner (intra-uterine device with&#xD;
             spermicide, hormonal contraceptive since at least two months)&#xD;
&#xD;
        In addition, the following trial-specific exclusion criteria apply:&#xD;
&#xD;
          -  Positive or missing fecal occult blood (no retest allowed),&#xD;
&#xD;
          -  Positive testing for fecal calprotectin (retest allowed)&#xD;
&#xD;
          -  Positive testing for hematuria if confirmed by microscopic urine analysis (retest&#xD;
             allowed)&#xD;
&#xD;
          -  Any lifetime history of suicidal behavior (i.e. actual attempt, interrupted attempt,&#xD;
             aborted attempt, or preparatory acts or behavior)&#xD;
&#xD;
          -  Any suicidal ideation (i.e. type 1-5) on the Columbia Suicidal Severity Rating&#xD;
             (C-SSRS) in the past 12 months (i.e.passive/active suicidal thought, active suicidal&#xD;
             thought with method, active suicidal thought with intent but without specific plan, or&#xD;
             active suicidal thought with plan and intent) (only Part 2)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</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>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 26, 2017</study_first_posted>
  <last_update_submitted>April 20, 2018</last_update_submitted>
  <last_update_submitted_qc>April 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 23, 2018</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/NCT03230487
org study id: 1305-0011
secondary id: 2017-002003-10
nct id: NCT03230487
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Part 1 (SRD (Single-rising dose)):

      The primary objective of this trial part is to investigate the safety and tolerability of BI
      1015550 in healthy male subjects following oral administration of single rising doses.

      Secondary objectives are the exploration of the pharmacokinetics of BI 1015550 after single
      dosing.

      Part 2 (MRD (Multiple-rising dose)):

      In Part 2, the primary objective is to investigate the safety and tolerability of BI 1015550
      in healthy male subjects following oral administration of multiple rising doses.

      Secondary objectives are the exploration of the pharmacokinetics of BI 1015550 after multiple
      dosing.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Number [N (%)] of subjects with drug-related Adverse Events (AEs)
time frame: Up to 9 days (Part 1)
measure: Number [N (%)] of subjects with drug-related Adverse Events (AEs)
time frame: Up to 28 days (Part 2)
measure: Part 1 (SRD): AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
time frame: up to 120 hours
measure: Part 1 (SRD): Cmax (maximum measured concentration of the analyte in plasma)
time frame: up to 120 hours
measure: Part 2 (MRD): After the first dose - AUCtau,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval tau after administration of the first dose)
time frame: up to 48 hours
measure: Part 2 (MRD): After the first dose - Cmax (maximum measured concentration of the analyte in plasma)
time frame: up to 48 hours
measure: Part 2 (MRD): After the last dose - AUCtau,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval tau)
time frame: up to 504 hours
measure: Part 2 (MRD): After the last dose - Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval tau)
time frame: up to 504 hours
measure: RA,Cmax (accumulation ratio based on Cmax,ss)
time frame: up to 504 hours
measure: RA,AUC (accumulation ratio based on AUC0-tau)
time frame: up to 504 hours
arm group label: BI 1015550
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: BI 1015550
description: Part 1 - single rising dose. Part 2 multiple rising dose
arm group label: BI 1015550
intervention type: Drug
intervention name: Placebo
description: Part 1 - single rising dose. Part 2 multiple rising dose
arm group label: Placebo
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Germany
responsible party type: Sponsor