This Study in Healthy Men Tests How the Body Takes up BI 1467335
Condition: Healthy
Intervention: BI 1467335; BI 1467335 (C-14) intravenous solution
Intervention description: Film-coated tablet; Intravenous solution
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: Male
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of this trial is to investigate the absolute bioavailability of BI
      1467335 with an intravenous microdose formulation containing labelled [C-14] BI 1467335 and
      an unlabelled oral tablet formulation of BI 1467335 in healthy male subjects.

      The secondary objective is the evaluation of additional pharmacokinetic parameters following
      the two treatments.
    

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 (ECG), and clinical laboratory tests

          -  Age of 18 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)
                  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 (ECG)) 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)e the reference range
             that the investigator considers to be of clinical relevance

          -  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 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

        In addition, the following trial-specific exclusion criteria apply:

        - Exposure to radiation for diagnostic reasons (except dental X-rays and plain X-rays of
        thorax and bony skeleton (excluding spinal column) in the period of 1 year prior to
        screening