Worsening chronic heart failure, Chronic Kidney Disease

Inclusion Criteria

- The informed consent must be signed before any study specific tests or procedures are done;
- Male participants and female participants without childbearing potential (postmenopausal women with 12 month of spontaneous amenorrhea or with 6 month of spontaneous amenorrhea and serum follicle-stimulating hormone (FSH) levels >30 mIU/mL; women with 6 weeks post bilateral ovarectomy, women with bilateral tubal ligation, and women with hysterectomy);
- Age: 18 to 79 years at the first screening examination;
- Race: White;
- Body mass index (BMI): ≥ 18 and  ≤ 34 kg / m2;

Participants with renal impairment
- Creatinine clearance (CLCR) ≤ 80 mL/min determined from a 24 hour urine collection interval 2 - 14 days prior to dosing;
- Stable renal disease, ie a serum creatinine value determined at least 3-6 months before the pre-study visit should not vary by more than 20% from the serum creatinine value determined at the pre-study visit;

Healthy participants
- Mean age and body weight in Group 1 (control group, healthy participants) and Groups 2 - 4 should not vary by more than +/- 10 years and +/- 10 kg, respectively.

Exclusion Criteria

- Participation in another clinical trial during the preceding 3 months for multiple dose studies and 1 month for single-dose studies; (final examination from previous study to first treatment of new study);
- Exclusion periods from other studies or simultaneous participation in other clinical studies;
- Donation of more than 100 mL of blood within 4 weeks before the first study drug administration or more than 500 mL in the preceding 3 months;
- Regular use of following medication during or within the 1 - 2 weeks preceding the study:
-- concomitant administration of other Aldosterone-antagonists (eg. eplerenone or spironolactone), potassium-sparing diuretics, potassium supplements, nonsteroidal anti-inflammatory drugs like ASS (secondary prevention with a dose of 100 mg daily is allowed), indomethacin or ibuprofen
-- concomitant use of cytochrome P450 isoenzyme 3A4 (CYP3A4) inducers (eg St. John´s wort, rifampicin, carbamazepin, phenytoin, phenobarbital, bosentan) 
-- concomitant use of weak to moderate CYP3A4 inhibitors (eg erythromycin, quinupristin/dalfopristin, saquinavir, fluconazole, amiodarone, diltiazem, fluvoxamine, verapamil, valproic acid, fluoxetine, grapefruit juice)
-- strong inhibitors of CYP3A4 (eg human immunodeficiency virus (HIV) protease inhibitors like indinavir, nelfinavir, ritonavir, atazanavir, lopinavir, amprenavir and saquinavir; macrolide/ketolide antibiotics like clarithromycin, telithromycin; antimycotic agents like itraconazole and ketoconazole [topical formulations will be allowed]; nefazodone)
-- moderate and strong inhibitors of cytochrome P450 isoenzyme 2C8 (CYP2C8) (eg gemfibrozil, montelukast, trimethoprim, glitazones)
- Women of childbearing potential, pregnant or lactating women;
- Positive results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), human immune deficiency virus antibodies (anti-HIV 1+2);
- Serum potassium level ≥ 5.5 mmol/L;
-  Serum sodium level ≤ 130 mmol/L;

For participants with renal impairment
- Acute renal failure;
- Acute nephritis;
- Any organ transplant;
- Failure of any other major organ system other than the kidney;
- Diastolic blood pressure (DBP) > 100 mmHg and/or systolic blood pressure (SBP) > 180 mmHg (at the pre-study examination; readings taken at the end of the dosing interval of antihypertensive medication, if any);
- Heart rate below 45 or above 110 BPM at screening visit;
- Hemoglobin < 8 g/dL;
- Serum albumin < 30 g/L;
- Severe cerebrovascular or cardiac disorders, eg myocardial infarction less than 6 months prior to dosing, congestive heart failure of New York Heart Association (NYHA) grade III or IV, decompensated heart failure, severe arrhythmia requiring antiarrhythmic treatment;

For healthy participants
- A history of relevant diseases of vital organs, of the central nervous system or other organs;
- Systolic blood pressure below 100 mmHg or above 145 mmHg;
- Diastolic blood pressure above 95 mmHg;
- Heart rate below 45 or above 95 BPM at screening visit;
- Clinically relevant deviations of the screened laboratory parameters in clinical chemistry, hematology, or urinalysis from reference range;
- Relevant deviation from the normal range in the clinical examination as judged by the investigator.