This Study Tests BI 1467335 in Healthy Male Volunteers. The Study Tests How Different Doses of BI 1467335 Are Taken up and Handled by the Body
Condition: Healthy
Intervention: [14C]BI 1467335; BI 1467335
Intervention description: Once Daily; Twice Daily
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: Male
Minimum age: 30 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Primary objective mass balance, excretion pathways and metabolism following a single oral
      dose of [14C]BI 1467335 given to healthy male subjects (a selected number of subjects will be
      treated with [14C]BI 1467335 after a preceding 27 days treatment with non-radiolabelled
      compound of BI 1467335 QD).

      Secondary objectives is to investigate the basic pharmacokinetics after single and multiple
      doses of BI 1467335 and its metabolites.
    

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 (Blood pressure (BP),
             Pulse rate (PR)), 12-lead Electrocardiogram, and clinical laboratory tests

          -  Age of 30 to 65 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

          -  Subjects who are sexually active must use, with their partner, highly effective
             contraception from the time of administration of trial medication until 4 months after
             administration of trial medication. --Adequate methods are:

               -  Condoms plus use of hormonal contraception by the female partner that started at
                  least 2 months prior to administration of trial medication (e.g., implants,
                  injectables, combined oral or vaginal contraceptives, intrauterine device) or

               -  Condoms plus surgical sterilization (vasectomy at least 1 year prior to
                  enrolment) or

               -  Condoms plus surgically sterilised partner (including hysterectomy) or

               -  Condoms plus intrauterine device or

               -  Condoms plus partner of non-childbearing potential (including homosexual men)

                    -  Subjects are required to use condoms to prevent unintended exposure of the
                       partner to the study drug via seminal fluid.

                    -  Alternatively, true abstinence is acceptable when it is in line with the
                       subject's preferred and usual lifestyle. If a subject is usually not
                       sexually active but becomes active, with their partner, they must comply
                       with the contraceptive requirements detailed above

        Exclusion Criteria:

          -  Any finding in the medical examination (including Blood pressure (BP), Pulse rate (PR)
             or Electrocardiogram) is deviating from normal and judged as clinically relevant by
             the investigator

          -  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

          -  Clinically significant gastrointestinal, hepatic, renal, respiratory (including but
             not limited to interstitial lung disease), 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)

          -  Within 30 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, or current
             participation in another trial involving administration of investigational drug

          -  Smoker (more than 5 cigarettes or 1 cigar or 1 pipe per day)

          -  Inability to refrain from smoking on specified trial days

          -  Average intake of more than 24 units of alcohol per week (1 unit of alcohol equals
             approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits)

          -  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

          -  Inability to comply with dietary regimen of trial site

          -  A marked baseline prolongation of QT/QTc interval (such as QTcF intervals that are
             repeatedly greater than 450 ms) or any other relevant Electrocardiogram 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