A Study in Healthy Japanese Men to Test How Different Doses of BI 894416 Are Tolerated
Condition: Healthy
Intervention: BI 894416; Placebo
Intervention description: BI 894416; Placebo
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 8.0
Sex: Male
Minimum age: 20 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of this trial is to investigate the safety, tolerability and pharmacokinetics
      of BI 894416 in healthy Japanese male subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy male subjects according to the assessment of the investigator, as based on a
             complete medical history, including a medical examination, vital signs (Blood pressure
             (BP), Pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests

          2. Japanese ethnicity, according to the following criteria:

             - born in Japan, have lived outside of Japan <10 years, and have parents and
             grandparents who are Japanese

          3. Age of 20 to 45 years (inclusive) at screening

          4. BMI of 18.5 to 25.0 kg/m2 (inclusive) at screening

          5. Signed and dated written informed consent prior to admission to the trial, in
             accordance with Good Clinical Practice (GCP) and local legislation

          6. Subjects who agree to minimize the risk of making their partner pregnant by fulfilling
             any of the following criteria starting from the first administration of trial
             medication until 90 days after last administration of trial medication

               -  Use of adequate contraception, any of the following methods plus condom:

        intrauterine device, combined oral contraceptives that started at least 2 months prior to
        the first drug administration

          -  Vasectomized (vasectomy at least 1 year prior to enrolment)

          -  Surgical sterilization (including bilateral tubal occlusion, hysterectomy or bilateral
             oophorectomy) of the subject's female partner

        Exclusion Criteria:

          1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal
             and assessed as clinically relevant by the investigator

          2. 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

          3. Any laboratory value outside the reference range that the investigator considers to be
             of clinical relevance

          4. Any evidence of a concomitant disease assessed as clinically relevant by the
             investigator

          5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
             immunological or hormonal disorders

          6. Cholecystectomy or other surgery of the gastrointestinal tract that could interfere
             with the pharmacokinetics of the trial medication, except appendectomy or simple
             hernia repair

          7. Diseases of the central nervous system, including but not limited to, any kind of
             seizures or stroke, and other relevant neurological or psychiatric disorders

          8. History of relevant orthostatic hypotension, fainting spells, or blackouts Further
             exclusion criteria apply.