Pharmacology, clinical

Inclusion Criteria

All subjects
   - Male and female Caucasian subjects between 18 and 79 years of age (both inclusive) with a body mass index above/equal 18.0 and below/equal 34.0 kg/m²
Subjects with hepatic impairment
    - Subjects with documented liver cirrhosis confirmed by histopathology, e.g., previous liver biopsy, laparoscopy, ultrasound, or fibroscan
    - Subjects with hepatic impairment as per Child Pugh system 
    - Subjects with stable liver disease during the last 2 months
Healthy subjects
    - Healthy subjects with mean age and body weight not varying by more than ±10 years and ±10 kg from the groups of subjects with mild and moderate hepatic impairment, respectively.

Exclusion Criteria

- Medical history of continent ileostomy.
- Febrile illness within 1 week prior to admission to study center.
- Known hypersensitivity to the study drug (active substances or excipients of the preparation).
- Subjects with diagnosed malignancy within the past 5 years.
- Use of any systemic or topical medicine or substances which oppose the study objectives or which might influence them, in particular: 
Starting from screening on, but minimum from 2 weeks before the study drug administration until the follow-up visit: 
    - CYP3A4 inducers 
    - CYP3A4 inhibitors 
    - Potent CYP2C8 inhibitors 
    - Major uridine diphosphate-glucuronosyltransferase isoenzyme 1A1 (UGT1A1) substrate (irinotecan)
On the day of administration of neladenoson bialanate:
    - Major breast cancer resistance protein (BCRP) substrates

- Regular daily consumption of more than 500 mL of usual beer or the equivalent quantity of of more than 2 units of alcohol in another form - Intake of ethanol containing food and beverages from 48 h prior to admission to the study center until 96 h after study drug administration, afterwards not more than 2 units of alcohol per day until follow-up examination.
- Intake of food and beverages containing grapefruit or pomelo from 14 days prior to study drug administration up to the last time point of PK sampling.
- Therapies (e.g. physiotherapy, acupuncture, etc.) within 1 week before study drug administration.
- Positive urine drug screening.
- Positive results for human immune deficiency - Abnormal (clinically significant) thyroid stimulating hormone (TSH).