This Study in Healthy Men Tests How Different Doses of BI 1265162 Are Taken up in the Body and How Well They Are Tolerated.
Condition: Healthy
Intervention: BI 1265162; Placebo
Intervention description: Multiple rising inhaled doses; Multiple rising inhaled doses
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 50.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of this trial is to investigate the safety and tolerability of BI
      1265162 in healthy male subjects following inhalative administration of multiple rising
      doses.

      Secondary objectives is the exploration of the pharmacokinetics (PK) including dose
      proportionality and time dependency of BI 1265162 after multiple dosing
    

Eligibility criteria:

        Inclusion criteria:

          -  Healthy male subjects according to the assessment of the investigator, based on a
             complete medical history including a physical examination, vital signs (Blood Pressure
             (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests

          -  Age of 18 to 45 years (incl.)

          -  Body mass index (BMI) of 18.5 to 29.9 kg/m2 (incl.)

          -  Forced expiratory volume in 1 second (FEV1) and Forced vital capacity (FVC) of equal
             or greater than 80% of predicted normal, at screening and prior to randomisation

          -  Signed and dated written informed consent prior to admission to the study in
             accordance with Good Clinical Practice (GCP) and local legislation

        Exclusion criteria:

          -  Any finding in the medical examination (including Blood Pressure (BP), Pulse Rate (PR)
             or Electrocardiogram (ECG)) is deviating from normal and judged as clinically relevant
             by the investigator

          -  Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg,
             diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the
             range of 50 to 90 beats per minute (bpm)

          -  Any laboratory value outside the reference range that the investigator considers to be
             of clinical relevance

          -  Any evidence of a concomitant disease judged as clinically relevant by the
             investigator

          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
             immunological or hormonal disorders

          -  Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with
             the pharmacokinetics of the trial medication (except appendectomy and simple hernia
             repair)

          -  Diseases of the central nervous system (including but not limited to any kind of
             seizures or stroke), and other relevant neurological or psychiatric disorders

          -  History of relevant orthostatic hypotension, fainting spells, or blackouts

          -  Chronic or relevant acute infections

          -  History of relevant allergy or hypersensitivity (including allergy to the trial
             medication or its excipients)

          -  Use of drugs within 30 days prior to administration of trial medication if that might
             reasonably influence the results of the trial (incl. QT/QTc interval prolongation)

          -  Participation in another trial where an investigational drug has been administered
             within 60 days prior to planned administration of trial medication, or current
             participation in another trial involving administration of investigational drug-
             Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)

          -  Inability to refrain from smoking on specified trial days

          -  Alcohol abuse (consumption of more 30 g per day for males)

          -  Drug abuse or positive drug screening

          -  Blood donation of more than 100 mL within 30 days prior to administration of trial
             medication or intended donation during the trial- Intention to perform excessive
             physical activities within one week prior to administration of trial medication or
             during the trial

          -  Inability to comply with dietary regimen of trial site

          -  A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are
             repeatedly greater than 450 ms in males) or any other relevant ECG finding at
             screening

          -  A history of additional risk factors for Torsades de Pointes (such as heart failure,
             hypokalemia, or family history of Long QT Syndrome)

          -  A history of chronic kidney disease (Estimated glomerular filtration rate (EGFR)<59
             mls/min including corrections as per ethnicity)

          -  Subject is assessed as unsuitable for inclusion by the investigator, for instance,
             because considered not able to understand and comply with study requirements, or has a
             condition that would not allow safe participation in the study

          -  The subject has a diagnosis history of pulmonary hyperreactivity

          -  Cannot use Respimat® appropriately

          -  Male subjects with woman of child bearing potential (WOCBP) partner who are unwilling
             to use male contraception (condom or sexual abstinence) from the first administration
             of trial medication until 14 days after last administration of trial medication (BI
             1265162 or placebo)