| Eligibility |
Inclusion criteria applicable to all participants
- Male or female participants
- Age of at least 18 years (inclusive)
- BMI of 18.5 to 35 kilogram per square metre (kg/m2) (inclusive)
- Signed and dated written informed consent in accordance with International Council for
Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) - Good
Clinical Practice (GCP) and local legislation prior to admission to the trial
- Male participants are not required to use contraception
- Woman of childbearing potential (WOCP) are allowed to participate provided they use a
highly effective contraception from at least 30 days before the administration of
trial medication until 30 days after trial completion. The following methods of
contraception are considered adequate for female participants of childbearing
potential:
- Use of combined (oestrogen and progestogen containing) hormonal contraception
that prevents ovulation (oral, intravaginal or transdermal), plus condom
- Use of progestogen-only hormonal contraception that inhibits ovulation (only
injectables or implants), plus condom
- Use of intrauterine device (IUD) or intrauterine hormone-releasing system (IUS)
- Sexually abstinent
- A vasectomised sexual partner who received medical assessment of the surgical
success (documented absence of sperm) and provided that partner is the sole
sexual partner of the trial participant.
Female participants are not considered to be of childbearing potential if they are either
surgically sterilised (including hysterectomy) or postmenopausal, defined as no menses for
1 year without an alternative medical cause (in questionable cases a blood sample with
levels of Follicle-stimulating hormone (FSH) above 40 Units per Litre (U/L) and oestradiol
below 30 nanogram per Litre (ng/L) is confirmatory)
Inclusion criteria applying only to participants with impaired renal function
- Renal impairment based on assessment of estimated Glomerular Filtration Rate (eGFR) at
screening (severe renal impairment: 15-29 millilitre per minute per 1.73 square metre
(mL/min/1.73 m2), moderate renal impairment: 30-59 mL/min/1.73 m2, mild renal
impairment: 60-89 mL/min/1.73 m2)
- Chronic renal impairment > 12 months (documented renal impairment indicated by reduced
eGFR for more than 12 months until screening)
- Absence of clinically significant abnormalities, as based on a complete medical
history including a full physical examination, vital signs (Blood Pressure (BP), Pulse
Rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests at both
screening and check-in, with the exception of findings that in the opinion of the
investigator are consistent with the participant's renal impairment
- Medication and/or treatment regimens must have been stable (i.e., no dose adjustments)
for at least 4 weeks prior to the screening period and should be kept stable until
study completion. Fluctuating treatment regimens may be considered for inclusion on a
case-by-case basis if the underlying disease is under control in the opinion of the
investigator and must be agreed to by both the investigator and the sponsor's medical
monitor
Inclusion criteria applying only to participants with normal renal function
- Individually matched to participants with renal impairment according to sex, age, and
weight, and race
- eGFR = 90 mL/min/1.73 m2
- Absence of clinically significant abnormalities identified by a detailed medical
history, full physical examination, vital signs and 12-lead ECG at both screening and
check-in visits
- Absence of clinically significant abnormalities identified by a laboratory test at
screening visit
Exclusion criteria applying to all participants
- Any evidence of a concomitant disease assessed as clinically relevant by the
investigator
- Cholecystectomy or other surgery of the gastrointestinal tract that could interfere
with the pharmacokinetics (PK) of the trial medication (except appendectomy or simple
hernia repair)
- Diseases of the Central Nervous System (CNS) (including but not limited to any kind of
seizures or stroke), and other relevant neurological or psychiatric disorders
(including but not limited to major depressive disorder)
- History of relevant orthostatic hypotension, fainting spells, or blackouts
- Relevant chronic or acute infections
- Any documented active or suspected malignancy or history of malignancy within 5 years
prior to screening, except appropriately treated basal cell carcinoma of the skin
- History of relevant allergy or hypersensitivity (including allergy to the trial
medication or its excipients)
- Use of drugs within 30 days (or 5 of its half-lives, whichever is longer) of planned
administration of trial medication that might reasonably influence the results of the
trial (including drugs that cause ECG interval from the start of the QRS complex to
the end of the T wave (QT interval) / QT interval corrected for heart rate, e.g. using
the method of Fridericia (QTcF) or Bazett (QTcB) (QTc interval) prolongation ) Further
exclusion criteria apply.
Exclusion criteria applying only to participants with renal impairment
- A marked prolongation of QT/QTc interval (such as QTc intervals that are repeatedly
greater than 480 milliseconds (ms) in males or repeatedly greater than 500 ms in
females) or any other relevant ECG finding at screening
- Acute renal failure or active nephritis
- Nephrotic syndrome
- Impaired hepatic function, including relevant increases in liver enzymes indicating
liver disease
- Relevant diseases for which it can be assumed that the absorption of the study drugs
will not be normal (i.e., relevant malabsorption, chronic diarrhoea)
- Participant under dialysis or planned to start dialysis during participation in the
study
- History of myocardial infarction, cerebrovascular accident or severe arrhythmia within
the 6 months prior to the screening visit.
- History of vascular surgery or intervention (e.g., coronary artery bypass,
percutaneous transluminal angioplasty etc.) less than 6 months prior to dosing Further
exclusion criteria apply.
Exclusion criteria applying only to participants with normal renal function
- Any finding in the medical examination (including BP, PR or ECG) deviating from normal
and assessed as clinically relevant by the investigator
- A marked prolongation of QT/QTc interval (such as QTc intervals that are repeatedly
greater than 450 ms in males or repeatedly greater than 470 ms in females) or any
other relevant ECG finding at screening
- Repeated measurement of systolic blood pressure outside the range of 90 to 140
millimetre of mercury (mmHg) (for participants older than 60 years: 90 to 150 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
- Any laboratory value outside the reference range that the investigator considers to be
of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
immunological or hormonal disorders
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