Table 3.
Comparison of unbound brigatinib plasma PK parameters in the hepatic impairment groups versus the healthy participants with normal hepatic function group
| Parameter |
Comparison
(vs normal hepatic function) |
Geometric LSM ratio, %
(90% CI) |
|---|---|---|
| Cmax,u (ng/mL) | Mild (Child-Pugh A) hepatic impairment | 94.75 (75.36–119.12) |
| Moderate (Child-Pugh B) hepatic impairment | 92.01 (73.18–115.68) | |
| Severe (Child-Pugh C) hepatic impairment | 165.26 (131.44–207.78) | |
| AUC0−last,u (h·ng/mL) | Mild (Child-Pugh A) hepatic impairment | 89.77 (70.37–114.52) |
| Moderate (Child-Pugh B) hepatic impairment | 99.41 (77.93–126.82) | |
| Severe (Child-Pugh C) hepatic impairment | 134.38 (105.34–171.43) | |
| AUC0−∞,u (h·ng/mL) | Mild (Child-Pugh A) hepatic impairment | 89.32 (69.79–114.31) |
| Moderate (Child-Pugh B) hepatic impairment | 99.55 (77.78–127.41) | |
| Severe (Child-Pugh C) hepatic impairment | 137.41 (107.37–175.86) |
AUC0−∞,u unbound area under the plasma concentration-time curve from time 0 to infinity, AUC0−last,u unbound area under the plasma concentration-time curve from time 0 to the time of the last measurable concentration, CI confidence interval, Cmax,u unbound maximum observed plasma concentration, LSM least-squares mean, PK pharmacokinetic