A Study in Healthy Men to Test How BI 730357 is Processed by the Body
Condition: Healthy
Intervention: BI 730357 mixed with [C-14]BI 730357 BS
Intervention description: Oral Solution
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: Male
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main objectives of the study are as follows:

        -  To assess the mass balance recovery of (C-14) BI 730357-radioactivity (also expressed as
           14C-BI 730357-EQ) in urine and faeces after a single oral dose of 50 mg BI 730357 base
           (BS) (C-14) in healthy male subjects

        -  To provide plasma, urine, and faecal samples for metabolite profiling and structural
           identification
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male subjects according to the assessment of the investigator, 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)
                  Subjects are required to use condoms to prevent unintended exposure of the
                  partner to the study drug via seminal fluid. Male and female condoms must not be
                  used together. Alternatively, true abstinence is acceptable when it is in line
                  with the subjec'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) is deviating from
             normal and judged 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 judged as clinically relevant by the
             investigator

          -  Clinically significant gastrointestinal (including known or suspected inflammatory
             bowel disease), hepatic, renal, respiratory, 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

          -  Further exclusion criteria apply