A Study in Healthy Men and Women to Test if Taking Different Formulations of BI 730357 Tablets Influences the Amount of BI 730357 in the Blood
Condition: Healthy
Intervention: BI 730357 (Test); BI 730357 (Reference)
Intervention description: tablet; tablet
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main objective of Trial Parts 1 and 2 is to investigate the relative bioavailability of
      two tablet strengths (low dose and high dose) of the intended Commercial Formulation of BI
      730357 (Test, T) versus with the corresponding tablet strengths of Trial Formulation 1
      (Reference, R).

      The main objective of Trial Part 3 is to investigate the relative bioavailability of two iCF
      side batches of BI 730357 with coarse milled Active pharmaceutical ingredient (API)(Test
      coarse milled, Tc) and unmilled API (Test unmilled, Tu), respectively, versus the final iCF
      batch of BI 730357 with regularly milled API (Reference, R).
    

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), PR), 12-lead Electrocardiogram (ECG), and clinical laboratory tests

          -  Age of 18 to 50 years (inclusive)

          -  Body mass index (BMI) of 18.5 to 29.9 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)

          -  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 U/L
             and estradiol below 30 ng/L is confirmatory)

        Exclusion Criteria:

          -  Any finding in the medical examination (including Blood pressure (BP), PR or
             Electrocardiogram (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 mmHg,
             diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the
             range of 45 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 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

          -  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 of planned administration of trial medication that might
             reasonably influence the results of the trial (including drugs that cause QT/QTc
             interval prolongation)

          -  Intake of an investigational drug in another clinical trial within 60 days of planned
             administration of investigational drug in the current trial, or concurrent
             participation in another clinical trial in which investigational drug is administered

          -  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 12 g per day for females and 24 g per day for
             males)

          -  Drug abuse or positive drug screening

          -  Blood donation of more than 100 mL within 30 days of planned administration of trial
             medication or intended blood donation during the trial

          -  Intention to perform excessive physical activities within one week prior to the
             administration of trial medication or during the trial

          -  Inability to comply with the 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 in males or repeatedly greater than 470 ms in females)
             or any other relevant ECG finding at screening

          -  A history of additional risk factors for Torsade de Pointes (such as heart failure,
             hypokalaemia, or family history of Long QT Syndrome)

          -  Subject is assessed as unsuitable for inclusion by the investigator, for instance,
             because the subject is not considered able to understand and comply with study
             requirements, or has a condition that would not allow safe participation in the study

          -  Female subjects will not be allowed to participate, if any of the following apply:

             -- Positive pregnancy test, pregnancy, or plans to become pregnant within 30 days
             after study completion

          -  Lactation

          -  Male subjects with Woman of childbearing potential (WOCBP) partner who are unwilling
             to use male contraception (condom or sexual abstinence) from time point of first
             administration of trial medication until 30 days after the last administration of
             trial medication

          -  Further exclusion criteria apply