TABLE 3.

Pharmacokinetics of BAY 1831865 in plasma (pharmacokinetic analysis set, n = 56)

Parameter	BAY 1831865
	3.5 mg i.v. a n = 3	7 mg i.v. n = 8	17 mg i.v. n = 8	35 mg i.v. n = 8	75 mg i.v. n = 8	150 mg i.v. n = 8	150 mg s.c. n = 8
AUC, mg.h/L	–	85.9 (58.1)	390 (32.4)	1530 (28.1)	3720 (32.6)	10 900 (16.7)	5160 (61.1)
AUC/D, h/L	–	12.3 (58.1)	23.0 (32.4)	43.6 (28.1)	49.6 (32.6)	72.9 (16.7)	34.4 (61.1)
Cmax , mg/L	1.32 (24.9)	2.15 (11.8)	5.73 (26.2)	13.7 (12.8)	21.7 (13.7)	48.3 (9.47)	10.9 (67.4)
Cmax/D, /L	0.378 (24.9)	0.307 (11.8)	0.337 (26.2)	0.392 (12.8)	0.289 (13.7)	0.322 (9.47)	0.0729 (67.4)
tmax , b h	1.02 (1.00–2.00)	1.00 (0.98–2.00)	1.47 (1.00–3.98)	2.00 (0.98–4.00)	1.93 (1.00–1.95)	1.94 (1.00–3.95)	96.0 (48–239)
t1/2 , h	–	28.4 (52.8)	61.6 (31.2)	107 (50.8)	164 (68.0)	208 (19.8)	217 (36.5)
CL or CL/F, c L/h	–	0.0815 (58.1)	0.0435 (32.4)	0.0229 (28.1)	0.0202 (32.6)	0.0137 (16.7)	0.0291 (61.1)
VSS or Vz/F, c L	–	3.36 (12.3)	3.63 (25.5)	3.35 (24.3)	4.67 (25.0)	4.17 (11.1)	9.10 (68.6)

Data presented as geometric mean (% coefficient of variance) unless otherwise stated.

Abbreviations: AUC, area under the plasma concentration‐time curve from zero to infinity; AUC/D, AUC divided by dose; CL, total body clearance of drug; CL/F, total body clearance of drug calculated after extravascular administration (e.g., apparent oral clearance); C_max, maximum observed drug concentration; C_max/D, C_max, divided by dose; i.v., intravenous; s.c., subcutaneous; t_1/2, half‐life associated with the terminal slope; t_max, time to C_max; V_ss, volume of distribution at steady state after intravascular administration; V_z/F, apparent volume of distribution during terminal phase after extravascular administration.

^a Plasma concentrations were only measurable in three volunteers, and not all parameters could be calculated.

^b Median (range).

^c CL and V_ss (i.v. administration); CL/F and V_z/F (s.c. administration).