Table 2.

Pharmacokinetic Parameters (Geometric Mean; Arithmetic Mean ± SD) of Upadacitinib in Subjects With Renal Impairment

	Degree of Renal Impairment
Parameter	Normal (N = 6)	Mild (N = 6)	Moderate (N = 5)a	Severe (N = 6)
Cmax (ng/mL)	29.4; 31.1 ± 11.8	30.8; 32.5 ± 10.2	27.3; 28.2 ± 8.05	33.2; 33.7 ± 5.96
Tmax b (h)	1.8 (1.0–6.0)	2.5 (1.5–6.0)	1.5 (1.0–6.0)	3.5 (2.0–6.0)
AUCt (ng • h/mL)	256; 265 ± 75.5	302; 314 ± 87.9	350; 358 ± 85.8	333; 337 ± 63.6
AUCinf (ng • h/mL)	260; 270 ± 77.7	310; 323 ± 90.7	352; 361 ± 86.9	337; 341 ± 63.2
t1/2 c (h)	11.0 ± 5.51	10.5 ± 7.00	10.4 ± 11.2	8.63 ± 4.43
fe (%)	9.24; 9.91 ± 4.05	6.51; 7.03 ± 3.05	4.60; 4.76 ± 1.34	2.10; 2.48 ± 1.62
CLR (L/h)	5.32; 5.64 ± 2.13	3.15; 3.42 ± 1.53	1.96; 2.14 ± 0.930	0.94; 1.06 ± 0.547

AUC_inf, area under the plasma concentration–time curve from time zero to infinite time; AUC_t, area under the plasma concentration–time curve from time zero to last measurable concentration; CL_R, renal clearance; C_max, maximum observed plasma concentration; f_e, the fraction of upadacitinib dose excreted unchanged in urine; t_1/2, terminal elimination half‐life; T_max, time to C_max.

^aSensitivity analysis excluding subject who had distinctively low upadacitinib exposure.

^bMedian.

^cHarmonic mean (pseudo‐standard deviation); evaluations of t_1/2 were based on statistical tests for β.