Chronic Kidney Disease, Renal Impairment, Healthy Volunteers

Inclusion Criteria

-  Participant must be 18 to 82 years of age inclusive, at the time of signing the informed consent.
 -  Normal kidney function or at different stages of renal impairment (mild to severe renal impairment, ESRD with hemodialysis or hemodiafiltration).
 -  Race: White (Note: Clinical Data Interchange Standards Consortium [CDISC] definition of White: Denotes a person with European, Middle Eastern, or North African ancestral origin who identifies, or is identified, as White [FDA]).
 -  Body mass index (BMI) within the range 18.0 and 35.0 kg/m^2 (both inclusive).
 -  Body weight equal or above 55 kg.
 -  Male or female participants; women have to be of non-childbearing potential as defined in Section 10.4.1 (e.g., postmenopausal for at least 1 year, women with bilateral salpingectomy, women with bilateral ovariectomy, and women with hysterectomy).
 -  Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies 
-  Men must agree to use a condom in sexual intercourse with female partner of childbearing potential and not to act as sperm donor for 10 days after dosing. 
 -  eGFR <90 mL/min/1.73 m^2 alculated by the CKD-EPI formula (eGFR must be repeated if screening period >10 days before dosing) 21 to 2 days prior to dosing and patients with ESRD on hemodialysis or hemodiafiltration. 
 -  Stable renal function (e.g., a serum creatinine value determined at least 3 months before the screening visit should not vary by more than 25% from the serum creatinine value determined at the screening visit).
-  eGFR ≥90 mL/min/1.73 m^2 calculated by the CKD-EPI formula (eGFR must be repeated if screening period >10 days before dosing) 21 to 2 days prior to dosing.
 -  Needs to be within the required matching age, gender, and body weight range.

Exclusion Criteria

-  Women of childbearing potential, pregnant or lactating women.
 -  Medical disorder, condition, or history of such that would impair the participant’s ability to participate or complete this study in the opinion of the investigator. 
 -  Known or suspected liver disorders (including Morbus Gilbert/Meulengracht) and bile secretion/flow (cholestasis).
 -  Known hypersensitivity to the study drugs (active substances or excipients of the preparations).
 -  Known severe allergies (e.g., allergies to more than 3 allergens, allergies affecting the lower respiratory tract – allergic asthma, allergies requiring therapy with corticosteroids), urticaria, or significant non-allergic drug reactions.
 -  Relevant acute diseases within the last 4 weeks prior to intake of study intervention.
 -  Febrile illness within 2 weeks before intake of study intervention.
 -  Known tendency for vasovagal reactions (e.g., after venipuncture) or clinically relevant history of syncope.
 -  History of gastrointestinal surgery, with the exception of appendectomy unless it had been performed within the previous 12 months before screening.
 -  Acute diarrhea or constipation within 14 days before intake of study intervention.
 -  Diagnosed malignancy within the past 5 years with exception of completely resected basal cell cancer of the skin (excision >6 months before screening).
 -  Planned intervention or surgery during the study which might impact the study objectives.
 -  History of clinically relevant bleeding within the past 3 months.
 -  Thrombotic disorder.
 -  Use of systemic or topical medicines or substances which oppose the study objectives
 -  Regular use of therapeutic or recreational drugs, e.g., carnitine products, anabolics, high dose vitamins (except for indicated medications for renally impaired).
 -  Use of any herbal products or St. John’s Wort within the last 14 days before intake of study intervention.
 -  Excluded therapies (e.g., physiotherapy, acupuncture, etc.) within 1 week before intake of study intervention.
 -  Change in chronic medications less than 2 weeks prior to dosing.
 -  Participation in another clinical study during the preceding 3 months for multiple dose studies and 1 month for single dose studies (last visit of participant to previous study to first treatment of new study).
 -  Exclusion periods from other studies or simultaneous participation in other clinical studies.
 -  Previous treatment during this study (allowing previously treated participants to be re-included into the study may lead to bias).
 -  Clinically relevant findings in the physical examination.
 -  Positive results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV) (and with a positive polymerase chain reaction [PCR] result or increased liver transaminases or other signs of liver disease), HIV antibodies 1+2/HIV p24 antigen (HIV-1/2 combi test).
 -  Positive urine/mouth swab drug screening indicating drug abuse.
 -  Positive alcohol breath test.
 -  Special diets preventing the participants from eating the standard meals during the study.
 -  Physical exercise within 96 h before admission the study site.
 -  Regular daily consumption of more than 1 L of methylxanthine-containing food or beverages.
 -  Consumption of methylxanthine-containing beverages or food (e.g., coffee, tea, cola drinks, and chocolate) within 48 h before intake of study intervention.
 -  Smoking more than 10 cigarettes per day.
 -  Regular daily consumption of more than 500  mL (male participants) or 250 mL (female participants) of usual beer or the equivalent quantity of approximately 20  g (male participants) or 10 g (female participants) of alcohol in another form.
 -  Intake of foods or beverages containing alcohol within 96 h before intake of study intervention.
 -  Donation of more than 100 mL of whole blood or plasma within 4 weeks or 500 mL whole blood within 3 months before intake of study intervention.
 -  Plasmapheresis within 3 months prior to study intervention.
 -  Suspicion of drug or alcohol abuse.