TABLE 4.

Summary of pharmacokinetic parameters for M16 (CMN288) by study group (pharmacokinetic analysis set)

Parameter	Statistics	Normal (n = 9)	Mild (n = 6)	Moderate (n = 8)	Severe (n = 6)
AUCinf (ng × h/mL)	Mean (SD)	4820 (1880)	2300 (691)	3850 (2490)	2350 (1200)
	GM	4560	2190	3400	2130
	CV% GM	35.2	37.4	52.0	49.5
AUClast (ng × h/mL)	Mean (SD)	4780 (1880)	2250 (677)	3830 (2490)	2330 (1210)
	GM	4520	2150	3370	2110
	CV% GM	35.8	37.2	52.4	50.0
Cmax (ng/mL)	Mean (SD)	1050 (328)	492 (272)	738 (645)	287 (130)
	GM	1010	423	587	262
	CV% GM	32.0	69.1	75.9	51.3
Tmax (h)	Median (range)	1.50 (1.00–2.00)	1.00 (1.00–2.00)	1.00 (1.00–3.00)	3.00 (1.50–6.00)
	GM	N/A	N/A	N/A	N/A
	CV% GM	N/A	N/A	N/A	N/A
t½ (h)	Mean (SD)	11.4 (6.92)	7.86 (5.49)	7.32 (5.16)	5.93 (0.907)
	GM	9.96	6.84	6.42	5.87
	CV% GM	57.9	55.6	50.8	14.8
Metabolite ratio of AUCinf (fold)	Mean (SD)	0.722 (0.181)	0.450 (0.0988)	0.680 (0.443)	0.276 (0.0802)
	GM	0.704	0.440	0.573	0.266
	CV% GM	24.1	23.8	67.7	32.2
Metabolite ratio of AUClast (fold)	Mean (SD)	0.720 (0.180)	0.447 (0.100)	0.680 (0.445)	0.274 (0.0795)
	GM	0.702	0.437	0.573	0.264
	CV% GM	24.0	24.1	68.0	32.2

AUC, area under the plasma concentration–time curve; AUC_inf, AUC from time zero to infinity; AUC_last, AUC from time zero to last measurable concentration sampling time; C_max, maximum (peak) observed plasma drug concentration after single‐dose administration; CV, coefficient of variation; GM, geometric mean; SD, standard deviation; t_½, elimination half‐life associated with terminal slope (λz) of a semilogarithmic concentration–time curve (time); T_max, time to reach maximum (peak) plasma drug concentration after single‐dose administration (time).

CV% GM = sqrt (exp [variance for log‐transformed data]‐1) × 100.