The study will investigate the pharmacokinetics of BAY1142524 in subjects with mild to severe renal impairment compared to age; weight, and gender-matched healthy subjects.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
36
single oral dose of 25 mg immediate-release tablet BAY1142524
CRS Clinical-Research-Services Kiel GmbH
Kiel, Schleswig-Holstein, Germany
Area under the concentration vs. time curve from zero to infinity after single (first) dose (AUC) of BAY1142524
AUC(0-tlast) will be used if mean AUC(tlast ∞) \>20% of AUC)
Time frame: Pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,6,8,10,12,15,24,36,48,96hours post dose
Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of BAY1142524
Time frame: Pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,6,8,10,12,15,24,36,48,96hours post dose
AUC of unbound drug (AUCu) of BAY1142524
AUC (0-tlast) u will be used if mean AUC (tlast ∞) \>20% of AUC). An additional blood sample for fu will be collected at 2 hours after dosing.
Time frame: Pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,6,8,10,12,15,24,36,48,96hours post dose
Cmax of unbound drug (Cmax,u) of BAY1142524
An additional blood sample for fu will be collected at 2 hours after dosing.
Time frame: Pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,6,8,10,12,15,24,36,48,96hours post dose
Number of subject with treatment emergent adverse events (TEAEs) as a measure of safety and tolerability
Time frame: up to 10 days after dosing
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