Table 3.
Plasma pharmacokinetic parameters and geometric least-squares mean ratios of pamiparib with (test) and without (reference) itraconazole in the PK analysis population
| Parameter | Pamiparib + itraconazole (test) N = 12 |
Pamiparib (reference) N = 12 |
GM ratioa (90% CI) |
|---|---|---|---|
| Cmax (ng/mL), GLSM (% CV) | 699 (37) | 665 (35) | 1.05 (0.95, 1.15) |
| AUC0–tlast (h ng/mL), GLSM (% CV) | 7793 (72) | 7837 (76) | 0.99 (0.91, 1.09) |
| AUC0–inf (h ng/mL), GLSM (% CV) | 8381 (78) | 8439 (83) | 0.99 (0.90, 1.09) |
| tmax (h), median (range) | 1.0 (0.95, 2.0) | 2.0 (0.98, 4.0) | NA |
| t1/2 (h), median (range) | 11.2 (3.7, 19.4) | 9.3 (4.5, 19.1) | NA |
| CL/F (L/h), GM (% CV) | 2.4 (78) | 2.4 (83) | NA |
AUC0–inf area under the plasma concentration–time curve from time zero to infinity, AUC0-tlast area under the plasma concentration–time curve from time zero to last measurement, CI confidence interval, CL/F apparent oral clearance, Cmax maximum plasma concentration, CV coefficient of variation, GLSM geometric least-squares mean, GM geometric mean, NA not applicable, PK pharmacokinetic, SD standard deviation, t1/2 time to one-half maximum plasma concentration, tmax time to maximum plasma concentration
aRatio defined as (GLSM test/GLSM reference)