Table 2.
Plasma pharmacokinetic parameters for unbound brigatinib
| Parametera | Normal Renal Function (n = 8) |
Severe Renal Impairment (n = 8) |
|---|---|---|
| Cmax,u (ng/mL) | 32.29 (25.1) | 36.76 (29.0) |
| Range | 23.9–45.3 | 25.2–55.6 |
| AUC0 − last,u (h·ng/mL) | 613.1 (22.4) | 1086 (27.3) |
| Range | 438–847 | 726–1544 |
| AUC0−∞,u (h·ng/mL) | 641.4 (22.2) | 1230 (30.6) |
| Range | 460–883 | 799–2017 |
| CL/F,u (L/h) | 140.3 (22.2) | 73.15 (30.6) |
| Range | 102–196 | 44.6–113 |
| V/F,u (L) | 8327 (30.4) | 5532 (31.4) |
| Range | 5898–13,744 | 3556–8914 |
AUC0−∞,u, unbound area under the plasma concentration-time curve from time zero to infinity; AUC0 − last,u, unbound area under the plasma concentration-time curve from time zero to the time of the last measurable concentration; CL/F,u, unbound apparent oral clearance; Cmax,u, unbound maximum observed plasma concentration; V/F,u, unbound apparent volume of distribution
a Data presented as geometric mean (geometric % coefficient of variation)