To investigate the pharmacokinetics of BAY1101042 in subjects with mild to severe renal impairment, stratified according to estimated glomerular filtration rate (eGFR) determined 2-10 days prior to dosing, and age-, weight- and gender- matched healthy subjects and to assess the safety, tolerability, and pharmacodynamics of BAY1101042 after a single oral dose of a 10 mg BAY1101042 given as 5 mg modified release (MR) tablet.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
36
Single oral dose of 10 mg BAY 1101042 (given as 5 mg MR tablets)
CRS Clinical-Research-Services Kiel GmbH
Kiel, Schleswig-Holstein, Germany
Area under the concentration vs. time curve from zero to infinity after single dose (AUC) of BAY1101042
Area under the concentration vs. time curve from zero to infinity after single dose of BAY1101042
Time frame: Study Day 1 to Study Day 6
Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of BAY1101042
Maximum observed concentration of BAY1101042 in plasma after single dose administration
Time frame: Study Day 1 to Study Day 6
AUCu of BAY1101042
Area under the unbound concentration vs. time curve from zero to infinity after single dose of BAY1101042
Time frame: Study Day 1 to Study Day 6
Cmax,u of BAY1101042
Maximum observed unbound concentration of BAY1101042 in plasma after single dose administration of BAY1101042
Time frame: Study Day 1 to Study Day 6
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.