A Study in Healthy People to Test Whether BI 730357 Affects How 4 Other Medicines (Rosuvastatin, Digoxin, Metformin, and Furosemide) Are Taken up in the Body
Condition: Healthy
Intervention: BI 730357; CRESTOR®; Lenoxin®; MetfoLiquid GeriaSan®; Lasix®
Intervention description: Film-coated tablet; Film-coated tablet; Tablet; Oral solution; Oral solution
Intervention MeSH terms: Metformin; Digoxin; Furosemide; Rosuvastatin Calcium
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main objective of this trial is to investigate the effect of BI 730357 under steady state
      conditions on the pharmacokinetics of digoxin, furosemide, metformin and rosuvastatin given
      as a cocktail (Reference, R: cocktail alone; Test T: cocktail given under steady state
      conditions of BI 730357).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy subjects according to the assessment of the investigator, as 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 55 years (inclusive)

          -  BMI of 18.5 to 29.9 kilogram per square meter (kg/m2) (inclusive)

          -  Signed and dated written informed consent prior to admission to the study, in
             accordance with Good Clinical Practice (GCP) and local legislation

          -  Male subjects, or female subjects who meet any of the following criteria from at least
             30 days before the first administration of trial medication until 30 days after trial
             completion: -- Use of adequate contraception, e.g. any of the following methods plus
             condom: implants, injectables, combined oral or vaginal contraceptives, intrauterine
             device

               -  Sexually abstinent

               -  A vasectomised sexual partner (vasectomy at least 1 year prior to enrolment)

               -  Surgically sterilised (including hysterectomy or bilateral tubal occlusion)

               -  Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in
                  questionable cases a blood sample with levels of Follicle-stimulating hormone
                  (FSH) above 40 units per liter (U/L) and estradiol below 30 nanograms per liter
                  (ng/L) is confirmatory)

        Exclusion Criteria:

          -  Any finding in the medical examination (including BP, PR or ECG) deviating from normal
             and assessed as clinically relevant by the investigator

          -  Repeated measurement of systolic blood pressure outside the range of 90 to 140
             millimetres of Mercury (mmHg), diastolic blood pressure outside the range of 50 to 90
             mmHg, or pulse rate outside the range of 45 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 assessed as clinically relevant by the
             investigator

          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
             immunological or hormonal disorders

          -  Cholecystectomy or other surgery of the gastrointestinal tract that could interfere
             with the pharmacokinetics of the trial medication (except appendectomy or 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

          -  During COVID-19 pandemic: laboratory test indicative of an ongoing SARS-CoV-2
             infection

          -  further exclusion criteria apply