Table 3.

Summary of CC-10004 (APR) Plasma Pharmacokinetic Parameters of after Administration of Apremilast Alone (i.e., Day 7) and Apremilast after Co-Administration with Methotrexate (MTX) (i.e., Day 8)

Treatment	Arithmetic Mean (Standard Deviation)
	tmaxa (hr)		Cmax (ng/mL)		Cmin (ng/mL)		AUC0–τ (hr ng/mL)		CLss/F (mL/min)
	APR	APR + MTX	APR	APR + MTX	APR	APR + MTX	APR	APR + MTX	APR	APR + MTX
Apremilast 30 mg Q12H (N = 15)	2.00 (0.95–4.00)	2.00 (0.98–4.08)	584 (198)	564 (204)	248 (153)	242 (153)	4,110 (1981)	4,120b (1991)	153 (78.6)	156b (86.3)
	N = 15	N = 15	N = 15	N = 15	N = 15	N = 15	N = 15	N = 13	N = 15	N = 13
Ratio of geometric means	0c		95.00		NC		99.30		NC
90% CI of ratio of geometric means	(−0.75, 0.74)d		(87.93, 102.65)		NC		(92.84, 106.20)		NC
Intra-subject CV%	1.000e		12.07		NC		9.66		NC
	N = 15		N = 15		NC		N = 15	N = 13	NC

N, number of subjects; CV, coefficient of variation; C_max, maximum observed plasma concentration; t_max, time to maximum plasma concentration; t_1/2, estimate of the terminal elimination half-life in plasma; AUC_0–t, area under the plasma concentration-time curve from time 0 to the last quantifiable concentration; AUC_0–∞, area under the plasma concentration-time curve from time 0 extrapolated to infinity; CL/F, apparent total plasma clearance when dosed orally; Vz/F, apparent total volume of distribution when dosed orally; NA, not applicable.

^at_max is summarized by median and range (minimum to maximum).

^bMean excludes data with R² < 0.9.

^cMedian difference (“APR + MTX” − “APR”).

^d90% CI of the median difference are from Hodges–Lehmann Estimate.

^eP-value is from Wilcoxon signed-rank test.