BAY 63-2521 is intended to be used for a disease that affects the blood flow through the lungs. Renal impairment is a common condition in patients with this disease. The goal of the study is to learn more about the safety of BAY 63-2521, how it is tolerated and the way the body absorbs, distributes and gets rid of the study dug given as a single oral dose of 1 mg tablet in participants with renal impairment and healthy participants matched for age-, gender-, and weight
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
40
0.5 mg riociguat as an immediate-release (IR) tablet
Unnamed facility
Kiel, Schleswig-Holstein, Germany
AUC
Area under the plasma concentration vs time curve from zero to infinity for total (bound and unbound) drug after single dose for BAY 63-2521 and its metabolite M1 (BAY 60-4552)
Time frame: Pre-dose up to 72 hours post-dose
Cmax
Maximum total (bound and unbound) drug concentration in plasma after single dose administration for BAY 63-2521 and its metabolite M1
Time frame: Pre-dose up to 72 hours post-dose
t½
Half-life associated with the terminal slope for BAY 63-2521 and its metabolite M1
Time frame: Pre-dose up to 72 hours post-dose
fu
Fraction unbound for BAY 63-2521 and its metabolite M1
Time frame: From 2 hours post-dose up to 24 hours post-dose
AUCu
AUC for unbound drug for BAY 63-2521 and its metabolite M1
Time frame: From 2 hours post-dose up to 24 hours post-dose
Cmax,u
Cmax for unbound drug for BAY 63-2521 and its metabolite M1
Time frame: From 2 hours post-dose up to 24 hours post-dose
AUC/D
AUC divided by dose for BAY 63-2521 and its metabolite M1
Time frame: Pre-dose up to 72 hours post-dose
AUCnorm
AUC divided by dose per kg body weight for BAY 63-2521 and its metabolite M1
Time frame: Pre-dose up to 72 hours post-dose
AUCu,norm
AUCnorm for unbound drug for BAY 63-2521 and its metabolite M1
Time frame: From 2 hours post-dose up to 24 hours post-dose
AUC(0-tlast)
AUC from time 0 to the last data point for BAY 63-2521 and its metabolite M1
Time frame: Pre-dose up to 72 hours post-dose
Cmax/D
Cmax divided by dose for BAY 63-2521 and its metabolite M1
Time frame: Pre-dose up to 72 hours post-dose
Cmax,norm
Cmax divided by dose per kg body weight for BAY 63-2521 and its metabolite M1
Time frame: Pre-dose up to 72 hours post-dose
Cmax,u,norm
Cmax,norm for unbound drug for BAY 63-2521 and its metabolite M1
Time frame: From 2 hours post-dose up to 24 hours post-dose
tmax
Time to reach Cmax (in case of two identical Cmax values, the first tmax was used) for BAY 63-2521 and its metabolite M1
Time frame: Pre-dose up to 72 hours post-dose
MRT
Mean residence time for BAY 63-2521 and its metabolite M1
Time frame: Pre-dose up to 72 hours post-dose
CL/F
Total body clearance of drug calculated after extravascular administration (eg apparent oral clearance) for BAY 63-2521 and its metabolite M1
Time frame: Pre-dose up to 72 hours post-dose
CLu/F
CL/F for unbound drug for BAY 63-2521 and its metabolite M1
Time frame: From 2 hours post-dose up to 24 hours post-dose
Vz/F
Apparent volume of distribution during terminal phase after extravascular administration for BAY 63-2521 and its metabolite M1
Time frame: Pre-dose up to 72 hours post-dose
AE,ur
Amount of (total) drug excreted in urine for BAY 63-2521 and its metabolite M1
Time frame: From 24 hours prior to drug administration up to 72 hours post-dose
CLR
Renal body clearance of drug for BAY 63-2521 and its metabolite M1
Time frame: From 24 hours prior to drug administration up to 72 hours post-dose
Number of participants with adverse events
Time frame: Approximately 5 weeks
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