Safety and Pharmacokinetics of Single Rising Doses of BI 705564 and Food Effect on BI 705564 in Healthy Male Subjects
Condition: Healthy
Intervention: Placebo; BI 705564 (Test); BI 705564 (Reference)
Intervention description: Tablet and solution formulation; Fed state; Fasting state
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 91.0
Sex: Male
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Investigation of safety, tolerability, pharmacokinetics and pharmacodynamics of single rising
      doses of BI 705564 and of the food effect on BI 705564 in healthy male subjects
    

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 50 years (incl.)

          -  Body Mass Index [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 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 140mmHg,
             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)

          -  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 than 30 g per day)

          -  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 the trial site

          -  A marked baseline prolongation of QT/ QTc interval (such as QTc intervals that are
             repeatedly greater than 450 ms) or any other relevant Electrocardiogram [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

        In addition, the following trial-specific exclusion criteria apply:

          -  Male subjects with women of childbearing potential [WOCBP] partner who are unwilling
             to use male contraception (condom or sexual abstinence) from the first administration
             of trial medication until 30 days after last administration of trial medication

          -  Repeated absolute B cell (CD19+) counts below 40/μL at screening

          -  Repeated platelet counts below 100 cells/nL at screening

          -  Serum potassium below normal range at screening

          -  A history or current clinical signs of acute pancreatitis