Table 2.
Summary of PK parameters of ixazomib (PK‐evaluable population)
| Parametera | Renal function group | ||
|---|---|---|---|
| Normal renal function (n = 18) | Severe RI (n = 14) | ESRD (n = 6) | |
| Total PK parameters | |||
| T max, hb | 1·04 (0·467–4) | 1·00 (0·45–1·5) | 1·25 (0·983–7) |
| C max, ng/ml | 25·8 (56) | 45·3 (81) | 18·7 (82) |
| AUC0–last, h·ng/ml | 575 (38)c | 813 (51)d | 783 (35) |
| Unbound PK parameters | |||
| C max, ng/ml | 0·300 (66) | 0·478 (86) | 0·213 (57) |
| AUC0–last, h·ng/ml | 6·64 (61)c | 9·25 (55)d | 8·93 (55) |
AUC0‐last, area under the concentration‐time curve from time 0 to the time of the last quantifiable concentration; C max, peak plasma concentration; ESRD, end‐stage renal disease requiring haemodialysis; PK, pharmacokinetics; RI, renal impairment; T max, the first observed time of C max.
a
Values shown are geometric mean (% coefficient of variation) unless otherwise specified.
b
Values are median (range).
c
n = 15.
d
n = 10.