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Clinical Trial Details

Trial ID: L0772
Source ID: NCT04908436
Associated Drug: Finerenone (Bay94-8862)
Title: A Study to Learn How BAY94-8862 Moves Into, Through and Out of the Body, How Safe it is and How it Affects the Body in Adult Participants With Reduced Kidney Function and in Healthy Participants With Similar Age, Weight and Gender Distribution
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Worsening Chronic Heart Failure|Chronic Kidney Disease
Interventions: DRUG: Finerenone (BAY94-8862)
Outcome Measures: Primary: Area under the plasma concentration vs time curve from zero to infinity for total (bound and unbound) drug after single dose administration of BAY94-8862 (AUC), AUC for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090), Up to 96 hours post-dose|Maximum total (bound and unbound) drug concentration in plasma after single dose administration of BAY94-8862 (Cmax), Cmax for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090), Up to 96 hours post-dose|AUC for unbound drug (AUCu), AUCu for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090), Up to 96 hours post-dose|Cmax for unbound drug (Cmax,u), Cmax,u BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090), Up to 96 hours post-dose|AUC divided by dose per kg body weight (AUCnorm), AUCnorm for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090), Up to 96 hours post-dose|AUCnorm for unbound drug (AUCu,norm), AUCu, norm for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090), Up to 96 hours post-dose|Cmax divided by dose per body weight (Cmax,norm), Cmax, norm for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090), Up to 96 hours post-dose|Cmax,norm for unbound drug (Cmax,u,norm), Cmax,u,norm for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090), Up to 96 hours post-dose | Secondary: Plasma renin activity (PRA), Change from baseline in plasma renin activity, Prior to dosing and 12 hours post-dose|Plasma angiotensin II, Change from baseline in plasma angiotensin II, Prior to dosing and 12 hours post-dose|Serum aldosterone, Change from baseline in serum aldosterone, Prior to dosing and 12 hours post-dose|Plasminogen activator inhibitor-1 (PAI-1), Change from baseline in PAI-1, Prior to dosing and 12 hours post-dose|Urinary volume, Change in volume of urine excreted, Prior to dosing up to 24 hours post-dose|Urinary creatinine, Change in urine creatinine concentrations, Prior to dosing up to 24 hours post-dose|Urinary electrolytes, Change in urinary electrolytes, Prior to dosing up to 24 hours post-dose|Half-life associated with the terminal slope (t½), t½ for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090), Up to 96 hours post-dose|Fraction unbound (fu), fu for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090), 1 hour and 6 hours post-dose|AUC divided by dose (AUC/D), AUC/D for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090), Up to 96 hours post-dose|AUC from time 0 to the last data point (AUC(0-tlast)), AUC(0-tlast) for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090), Up to 96 hours post-dose|Cmax divided by dose (Cmax/D), Cmax/D for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090), Up to 96 hours post-dose|Time to reach Cmax (tmax), Time to reach Cmax (in case of two identical Cmax values, the first tmax was to be used) for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090), Up to 96 hours post-dose|Mean residence time (MRT), MRT for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090), Up to 96 hours post-dose|Total body clearance of drug calculated after extravascular administration (CL/F), CL/F for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090), Up to 96 hours post-dose|Total body clearance of unbound drug from plasma calculated after oral administration (apparent oral unbound clearance) (CLu/F), CLu/F for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090), Up to 96 hours post-dose|Apparent volume of distribution during terminal phase after extravascular administration (Vz/F), Vz/F for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090), Up to 96 hours post-dose|Amount excreted into urine from 0 to 96 h (end of urine sampling) after study drug administration (AE,ur), AE,ur for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090), Up to 96 hours post-dose|Percent amount excreted into urine from 0 to 96 h (end of urine sampling) after study drug administration (%AE,ur), %AE,ur for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090), Up to 96 hours post-dose|Renal body clearance of drug (CLR), CLR of BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090), Up to 96 hours post-dose|Number of participants with adverse events, Approximately 5 weeks
Sponsor/Collaborators: Sponsor: Bayer
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 33
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2010-10-27
Completion Date: 2012-01-27
Results First Posted:
Last Update Posted: 2022-01-28
Locations: Kiel, Schleswig-Holstein, 24105, Germany
URL: https://clinicaltrials.gov/show/NCT04908436