Pharmacology, clinical

Inclusion Criteria

All subjects:
    - Male or female White subjects (women without childbearing potential), aged 18 to 79 years (inclusive), body mass index 18 to 34 kg/m² (both inclusive)
Subjects with renal impairment:
    - Estimated glomerular filtration rate (eGFR)  <90 mL/min/1.73 m² determined from serum creatinine 2–14 days prior to dosing using the Modification of Diet in Renal Disease equation
    - Stable renal disease, i.e. a serum creatinine value determined at least 3 months before the pre-study visit should not vary by more than 25% from the serum creatinine value determined at the pre-study visit.
Healthy subjects:
     - Age-, weight- and gender matched healthy subjects

Exclusion Criteria

- An anatomical abnormality of the gut (e.g. gut surgery, continent ileostomy) that could affect the retention times of the drug in the stomach/gut adversely
- Gastric vagotomy or other condition that might adversely affect the gastric pH level
- Pancreatic dysfunction/insufficiency
- Febrile illness within 1 week prior to admission to study center
- Use of the following co-medications 
From 2 weeks before administration until end of follow-up:
    - Cytochrome P450 (CYP)3A4 inhibitors (Of note: grapefruit is a strong CYP3A4 inhibitor) 
    - CYP3A4 inducers 
    - CYP2C8 inhibitors (Of note: clopidogrel is a strong CYP2C8 inhibitor) 
    - Theophylline
On the day of dosing with neladenoson bialanate:
    - Drugs that undergo significant systemic metabolism over gut wall uridine diphosphate-glucuronosyltransferase 1A1 (UGT1A1) substrates (e.g. irinotecan)
    - Major breast cancer resistance protein (BCRP) substrates 
- Regular daily consumption of more than 1 L - Plasmapheresis within 4 weeks before study drug administration
- Therapies (e.g. physiotherapy, acupuncture, etc.) within 1 week before study drug administration
- History of relevant and not cured cardiac rhythm disorders (i.e. Wolff-Parkinson-White syndrome, intermittent second- or third-degree AV block)
- Positive urine drug screening
- Subjects tested to be positive for hepatitis B surface antigen (HBsAg) or hepatitis C virus