Pharmacokinetics and safety of ixazomib plus lenalidomide–dexamethasone in Asian patients with relapsed/refractory myeloma: a phase 1 study

Table 2 Plasma PK parameters of ixazomib on day 1 and day 15 of cycle 1

Parameter	Chinese	Korean	Other^a	Overall
Day 1	n = 16	n = 16^b	n = 6	n = 38^c
T _max, h^d	1.04 (0.5–7.0)	1.95 (0.5–8.0)	1.75 (0.5–7.0)	1.5 (0.5–8.0)
C _max, ng/mL	50.6 (102)	22.1 (99)	35.7 (118)	33.8 (115)
AUC_0–168, h*ng/mL	933 (83)	630 (47)	720 (63)	776 (78)
DN C _max, ng/mL/mg	12.6 (102)	5.53 (99)	8.93 (118)	8.45 (115)
DN AUC_0–168, h*ng/mL/mg	233 (83)	157 (47)	180 (63)	194 (78)
Day 15	n = 15^e	n = 13^f	n = 4	n = 32^g
T _max, h^d	2 (0.5–7.08)	2 (0.48–7.97)	1.25 (0.5–4.0)	2.0 (0.48–7.97)
C _max, ng/mL	50.3 (71)	38.0 (67)	42.4 (97)	43.9 (72)
AUC_0–168, h*ng/mL	1750 (39)	1450 (49)	1530 (81)	1610 (48)
DN C _max, ng/mL/mg	12.6 (71)	9.51 (67)	10.6 (97)	11.0 (72)
DN AUC_0–168, h*ng/mL/mg	438 (39)	362 (49)	383 (81)	401 (48)
t_1/2, h	148 (20)	145 (20)	148 (7)	147 (18)
Accumulation ratio	2.38 (30)	2.34 (40)	2.56 (33)	2.39 (33)

Data are given as geometric mean (% CV), unless otherwise specified
AUC _0–168 area under the plasma concentration–time curve from 0 to 168 h post-dose, C _max maximum observed plasma concentration, DN dose-normalized, t _1/2 half-life of the terminal disposition phase, T _max time of C_max
^aDay 1: Malaysian (n = 3), Asian Indian (n = 2), Indonesian (n = 1); day 15: Malaysian (n = 3), Indonesian (n = 1)
^b n = 12 for AUC_0–168
^c n = 34 for AUC_0–168
^dMedian (range)
^e n = 14 for t_1/2 and n = 12 for accumulation ratio
^f n = 11 for AUC_0–168 and t_1/2 and n = 9 for accumulation ratio
^g n = 30 for AUC_0–168, n = 29 for t_1/2, and n = 25 for accumulation ratio

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