Table 2.
Summary of the effect of moderate hepatic impairment on niraparib PK: ratio of moderate hepatic impairment to normal hepatic function
| Parameter | n | Mean (SE) | Geometric LS mean (SE)a | Ratio (moderate/normal) | |
|---|---|---|---|---|---|
| Geometric LS mean ratio (SE)a | 90% CIa | ||||
| Cmax (ng/mL) | |||||
| Moderate hepatic impairment | 8 | 601.00 (88.96) | 552.68 (86.35) | 0.9305 (0.1998) | 0.6386–1.3558 |
| Normal hepatic function | 9 | 644.00 (91.98) | 593.96 (87.49) | ||
| AUClast (h × ng/mL) | |||||
| Moderate hepatic impairment | 8 | 29,317.51 (4393.22) | 26,825.19 (3948.56) | 1.4528 (0.2939) | 1.0190–2.0712 |
| Normal hepatic function | 9 | 19,545.11 (2291.79) | 18,464.93 (2562.52) | ||
| AUCinf (h × ng/mL) | |||||
| Moderate hepatic impairment | 7 | 34,265.92 (6296.04) | 30,802.12 (5078.95) | 1.5639 (0.3438) | 1.0618–2.3034 |
| Normal hepatic function | 9 | 20,915.19 (2525.24) | 19,696.31 (2864.21) | ||
AUCinf area under the concentration–time curve extrapolated to infinity, AUClast area under the concentration–time curve calculated to last measured concentration, CI confidence interval, Cmax observed maximum plasma concentration, SE standard error, LS least squares
aFrom an ANOVA model for the log-transformed parameter results with fixed effect hepatic impairment group