A Study to Learn How the Study Treatment BAY1753011 Moves Into, Through and Out of the Body, How it Works, How Safe it is, and How it Affects the Body When Given Once as Tablet in Male and Female Participants With Reduced Kidney Function Compared to Matched Participants With Normal Kidney Function
Congestive Heart Failure, Renal Impairment
About this trial
This is an interventional basic science trial for Congestive Heart Failure
Eligibility Criteria
Inclusion Criteria: Male or female White participants (women without childbearing potential) Aged from ≥18 years body mass index above or equal 18.5 kg/m2 and below or equal 36 kg/m2 at the first screening visit Participants with renal impairment: with an eGFR <90 mL/min/1.73 m^2 determined from serum creatinine 21-3 days prior to dosing using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation Age-, weight- and gender- matched control group Exclusion Criteria: An anatomical abnormality of the gut that could affect the retention times of the drug in the stomach/gut adversely Conditions or concomitant treatment that might adversely affect the gastric pH level Pancreatic dysfunction/insufficiency Febrile illness within 4 week prior to admission to study center Known hypersensitivity to the study drugs Known severe allergies, non-allergic drug reactions, or multiple drug allergies Participants with a 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 or the Sponsor Concomitant treatment from 2 weeks before study drug administration until end of follow-up with drugs that may impact the PK of BAY 1753011:Strong and moderate inducers or inhibitors of CYP3A4Moderate and strong inhibitors of P-gp transport Probenecid and valproic acid Concomitant treatment with potassium-sparing diuretic (with the exception of mineralocorticoid- receptor antagonist [MRA]) that cannot be stopped prior to randomization and for the duration of the treatment period Although no clinical study data are available for BAY 1753011, drugs for the treatment of hyperphosphatemia such as sevelamer or lanthanum should not be given from 24 h before until 24 h after dosing, as they are known to bind many anionic drugs Acute renal failure Active nephritis Severe infection or any clinically significant illness within 4 weeks prior to dosing Impairment of any other major organ system other than the kidney Clinically relevant findings in the ECG such as a second- or third-degree atrioventricular (AV) block, prolongation of the QTc-interval over 480 msec Systolic blood pressure below 100 or above 160 mmHg Diastolic blood pressure below 50 or above 100 mmHg Heart rate below 50 or above 100 beats/ min
Sites / Locations
- APEX GmbH
- CRS Clinical-Research-Services Kiel GmbH
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Healthy
Mild renal impairment
Moderate renal impairment
Severe renal impairment
Age-, weight- and gender- matched control group of healthy volunteers received a single oral dose of 30 mg BAY1753011 tablet.
Subjects with mild renal impairment received a single oral dose of 30 mg BAY1753011 tablet.
Subjects with moderate renal impairment received a single oral dose of 30 mg BAY1753011 tablet.
Subjects with severe renal impairment received a single oral dose of 15 mg BAY1753011 tablet.