|
Parameter
|
Group 1 (CRCL > 80 mL/min) n = 16
|
Group 2 (CRCL 50–80 mL/min) n = 15
|
Group 3 (CRCL 30–49 mL/min) n = 16
|
Group 4a (CRCL < 30 mL/min) n = 16
|
|---|
|
AUC, μg·h/L
|
245.7 (51)
|
347.5 (111)
|
499.0 (110)
|
523.0 (70.4)b
|
|
Cmax, μg/L
|
36.6 (17)
|
44.2 (21)
|
42.0 (32)
|
40.56 (37.8)b
|
|
AUCnorm, kg·h/L
|
20.6 (56)
|
29.4 (126)
|
42.1 (109)
|
29.7 (102)
|
|
Cmax,norm, kg/L
|
3.07 (17)
|
3.48 (25)
|
3.54 (30)
|
2.97 (40)
|
|
t½, h
|
6.19 (50)
|
10.1 (116)
|
11.4 (103)
|
9.52 (75)
|
- aIn the first study, individuals with severe renal impairment (group 4) received riociguat 0.5 mg; all other participants in both studies received riociguat 1 mg.
- bAUC and Cmax values shown for individuals with severe renal impairment (group 4) are taken from the second study (n = 8), in which individuals with severe renal impairment received riociguat 1.0 mg.
- Values are geometric means (percentage coefficient of variation). AUC, area under the plasma concentration–time curve from time 0 to infinity; AUCnorm, AUC divided by dose per kilogram of body weight for total riociguat; Cmax, maximum concentration in plasma; Cmax,norm, Cmax divided by dose per kilogram of body weight for total riociguat; t½, terminal elimination half-life for total riociguat.
