Multiple Rising Oral Doses of BI 691751 in Healthy Male Subjects
Condition: Healthy
Intervention: BI 691751; BI 691751; BI 691751; BI 691751; BI 691751; BI 691751; Placebo
Intervention description: BI 691751 Dose 1; BI 691751 Dose 2; BI 691751 Dose 3; BI 691751 Dose 4; BI 691751 Dose 5; BI 691751 Dose 6; Placebo
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 18.0
Sex: Male
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      It is the objective of this MRD trial to investigate pharmacokinetics, pharmcodynamics,
      safety and tolerability of rising doses BI 691751 over a treatment period of 14 days to
      support the further clinical development of this LTA4H-inhibitor. Special emphasis will be
      given to detect potential effects of BI 691751 on heart rate.
    

Eligibility criteria:

        Inclusion criteria:

          -  Healthy male subjects according to the investigator´s assessment, based on a complete
             medical history including a physical examination, vital signs (BP (blood pressure), PR
             (pulse rate), 12-lead ECG (electro cardiogramm), and clinical laboratory tests

          -  Age of 18 to 50 years (incl.)

          -  BMI (body mass index) of 18.5 to 29.9 kg/m2 (incl.)

          -  Signed and dated written informed consent prior to admission to the study in
             accordance with GCP(Good Clinical Practice) and local legislation

          -  Subject is able to understand and communicate in German

        Exclusion criteria:

          -  Any finding in the medical examination (including BP (blood pressure), PR (pulse rate)
             or ECG (electro cardiogramm) is deviating from normal and judged as clinically
             relevant by the investigator

          -  Pulse rate outside 45-80 bpm (beats per minutes) or repeated measurement of systolic
             blood pressure greater than 140 mmHg, diastolic blood pressure greater than 90 mm Hg

          -  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

          -  Surgery of the gastrointestinal tract that could interfere with kinetics of the trial
             medication

          -  Diseases of the central nervous system (such as epilepsy), other neurological
             disorders 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 during inhouse-confinement

          -  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

          -  Vulnerable subjects, e.g. subjects kept in detention, soldiers, employees of the
             sponsor or a clinical research organization, involved in this study