To Assess Safety, Tolerability and Pharmacokinetics of BI 443651 in Healthy Male Volunteers
Condition: Healthy
Intervention: BI 443651; Placebo
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 63.0
Sex: Male
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To investigate safety, tolerability and pharmacokinetics, following single doses of BI 443651
    

Eligibility criteria:

        Inclusion criteria:

          -  Healthy male according to the investigators assessment, based on a complete medical
             history including a physical examination, vital signs (BP, PR), 12-lead ECG, and
             clinical laboratory tests

          -  Age of 18 to 50 years (incl.)

          -  BMI of 18.5 to 29.9 kg/m2 (incl.)

          -  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 BP, PR or 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 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)

          -  Intake of drugs with a long half-life (more than 24 h) within 30 days or less than 10
             half-lives of the respective drug prior to administration of trial medication

          -  Within 10 days prior to administration of trial medication, use of drugs that might
             reasonably influence the results of the trial or that might prolong the QT/QTc
             interval

          -  Participation in another trial where an investigational drug has been administered
             within 60 days prior to planned administration of trial medication

          -  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)

          -  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.

          -  Estimated glomerular filtration rate (eGFR) below 80 mL/min