| Eligibility |
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 Electrocardiogram (ECG), and clinical laboratory tests
- Age of 18 to 45 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
- Willingness to comply with contraception requirements. Subjects who are sexually
active must use adequate contraception with their female partner throughout the study
and until 1 month after the last administration of trial medication. Adequate methods
are:
- Sexual abstinence or
- A vasectomy performed at least 1 year prior to screening (with medical assessment
of the surgical success) or
- Surgical sterilisation (including bilateral tubal occlusion, hysterectomy or
bilateral oophorectomy) of the subject's female partner or
- The use of condoms, if the female partner uses an adequate contraception method
in addition, e.g., intrauterine device (IUD), hormonal contraception (e.g.
implants, injectables, combined oral or vaginal contraceptives) that started at
least 2 months prior to first drug administration, or barrier method (e.g.
diaphragm with spermicide) Unprotected sexual intercourse with a female partner
is not allowed throughout the study and until 1 month after the last
administration of trial medication.
Exclusion criteria:
- Any finding in the medical examination (including Blood pressure (BP), Pulse rate (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 50 to 90 beats per minute (bpm)
- C-reactive protein (CRP)> Upper limit of normal (ULN), Erythrocyte sedimentation rate
(ESR)=15 millimeters/h, liver or kidney parameter above ULN, or any other 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
medications or their 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)
- 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 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 30 g per day)
- 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 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
- Any lifetime history of suicidal behaviour (i.e. actual attempt, interrupted attempt,
aborted attempt, or preparatory acts or behaviour)
- Any suicidal ideation of type 2 to 5 on the Columbia Suicide Severity Rating Scale
(C-SSRS) in the past 12 months (i.e. active suicidal thought, active suicidal thought
with method, active suicidal thought with intent but without specific plan, or active
suicidal thought with plan and intent)
- Any history of drug-induced liver failure.
- History of ventricular dysfunction or congestive heart failure.
- Further exclusion criteria apply
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