A Study in Healthy Men to Test How BI 1265162 is Taken up and Processed by the Body
Condition: Healthy Volunteers
Intervention: Part 1: BI 1265162 - intravenous; Part 2: BI 1265162 - oral
Intervention description: Intravenous solution; Oral solution
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: Male
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To investigate rates and routes of excretion, mass balance, pharmacokinetics of parent drug,
      any known metabolites, and total radioactivity, metabolite profiling, metabolite
      identification, if suitable assays are available, safety and tolerability in healthy male
      subjects.
    

Eligibility criteria:

        Inclusion criteria

          -  Healthy male 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 electrocrdiogram (ECG), and clinical laboratory tests

          -  Age of 18 to 65 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 trial, 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 3 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-child bearing potential (including homosexual men)
                  Subjects are required to use condoms to prevent unintended exposure of the
                  partner to the trial 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 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 139 mmHg,
             diastolic blood pressure outside the range of 45 to 89 mmHg, or pulse rate outside the
             range of 40 to 100 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

          -  Clinically significant 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

          -  Smoking habit other than incidental. Incidental smoker is defined as a person who will
             not smoke more than 5 cigarettes per week

          -  Inability to refrain from smoking in the clinical research unit

          -  Alcohol abuse (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 of planned administration of trial
             medication or intended blood donation during the trial

          -  Intention to perform excessive physical activities within 96 hours prior to the
             administration of trial medication and during the trial until the discharge at Day 9

          -  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) 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 trial
             requirements, or has a condition that would not allow safe participation in the trial

        In addition, the following trial-specific exclusion criteria apply:

          -  A history of chronic kidney disease

          -  Participation in another absorption, distribution, metabolism, and excretion (ADME)
             study with a radiation burden of 0.1-1.0 millisievert (mSv) in the period of 1 year
             prior to screening or 1.1-2.0 mSv in the past 2 years or 2.1-3.0 mSv in the past 3
             years etc.

          -  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)

          -  Irregular defecation pattern (less than a mean of one bowel movement every other day)