. 2015 Apr 28;54(10):1043–1055. doi: 10.1007/s40262-015-0271-5

Table 5.

Pharmacokinetic parameters of enzalutamide after a single oral dose in healthy male volunteers and male subjects with impaired hepatic function

Study	Dose (mg)	Subjects (n)	C _max (μg/mL)^a	t _max (h)^b	AUC_∞ (μg·h/mL)^a	t _½ (days)^a	CL/F (L/h)^a	V _z/F (L)^a
Mass balance^c	160 (fasted)	6	4.5 ± 0.9	1.8 [1.0–3.0]	237 ± 50	2.9 ± 0.3	0.71 ± 0.17	72 ± 21
Food-effect^d	160 (fasted)	30	5.3 ± 1.1	1.0 [0.8–3.1]	292 ± 88	3.9 ± 1.3	0.60 ± 0.19	76 ± 22
	160 (fed)	30	3.7 ± 1.2	2.0 [0.5–6.0]	285 ± 73	3.6 ± 1.0	0.60 ± 0.16	72 ± 17
Hepatic^e	160 (fasted)^f	6	3.7 ± 1.3	1.3[0.5–2.0]	246 ± 68	4.8 ± 1.8	0.69 ± 0.18	117 ± 58
	160 (fasted)^g	8	3.8 ± 0.8	1.0 [0.8–2.0]	225 ± 51	4.5 ± 2.2	0.75 ± 0.21	109 ± 41
	160 (fasted)^h	6	4.4 ± 0.8	0.8 [0.5–2.0]	253 ± 42	3.5 ± 1.0	0.65 ± 0.12	77 ± 23
	160 (fasted)ⁱ	8	3.7 ± 2.1	1.0 [0.5–2.0]	303 ± 126	8.2 ± 7.7	0.60 ± 0.23	142 ± 105

AUC _∞ area under the plasma concentration–time curve from time zero to infinity, CL/F apparent oral clearance, C _max maximum plasma concentration, t _½ half-life, t _max time to reach C _max, V _z /F apparent volume of distribution during the terminal phase

^aValues are expressed as mean ± standard deviation

^bValues are expressed as median [range]

^cMass balance and biotransformation study

^dFood-effect study

^eHepatic impairment study

^fSubjects with normal hepatic function who served as controls for the mild hepatic impairment arm

^gSubjects with normal hepatic function who served as controls for the moderate hepatic impairment arm

^hSubjects with mild hepatic impairment

ⁱSubjects with moderate hepatic impairment