Table 2.
Plasma pharmacokinetic parameters and geometric least-squares mean ratios of pamiparib with and without rifampin in the PK analysis population
| Parameter | Pamiparib + rifampin (test) N = 11 |
Pamiparib (reference) N = 11 |
GM Ratioa (90% CI) |
|---|---|---|---|
| Cmax (ng/mL), GLSM (% CV) | 1861 (20) | 1986 (26) | 0.94 (0.83, 1.06) |
| AUC0–tlast (h ng/mL), GLSM (% CV) | 17,762 (27) | 28,841 (37) | 0.62 (0.54, 0.70) |
| AUC0–inf (h ng/mL), GLSM (% CV) | 18,080 (29) | 29,480 (43)b | 0.57 (0.48, 0.69) |
| tmax (h), median (range) | 2.0 (1.0, 4.0) | 2.0 (1.0, 4.0) | NA |
| t1/2 (h), median (range) | 7.7 (5.1, 11.4) | 13.4 (6.8, 20.0)b | NA |
| CL/F (L/h), GM (% CV) | 3.3 (29) | 2.0 (43)b | 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)
bN = 9