Table 3.
Summary of single‐dose and steady‐state pharmacokinetic parameters of pamiparib
| N |
Cmax (ng/ml) |
Tmax a (hr) |
AUC0‐9 (ng/ml*h) |
AUC0‐12 (ng/ml*h) |
AUC0‐inf (ng/ml*h) |
t1/2 b (hr) |
CL/F (L/hr) |
Vz/F (L) |
|
|---|---|---|---|---|---|---|---|---|---|
| Single dose | |||||||||
| 20 mg BID | 4 | 718.4 (18.9) | 1.01 (0.52, 3.78) | 4129.9 (13.1) | 5033.4 (16.6) | 10240.5 (43.9) | 12.14 (8.15, 18.15) | 1.95 (44) | 3.42 (24) |
| 40 mg BID | 4 | 1633.7 (12.2) | 0.98 (0.97, 1.05) | 8557.6 (20.1) | 10364.2 (22.7) | 19312.7 (61.1) | 11.79 (8.74, 20.14) | 2.07 (61) | 3.52 (22) |
| 60 mg BID | 7 | 2302.5 (30.1) | 1.13 (1.00, 6.08) | 11895.2 (47.0) | 14826.0 (47.7) | 27454.4 (79.4) | 13.77 (6.54, 34.91) | 2.19 (79) | 3.72 (33) |
| Steady state | |||||||||
| 20 mg BID | 4 | 1280.1 (70.5) | 1.04 (0.92, 2.12) | 8357.6 (67.7) | 10317.2 (68.6) | NA | NA | NA | NA |
| 40 mg BID | 4 | 5213.8 (25.6) | 1.10 (0.98, 1.95) | 32469.1 (28.6) | 40906.1 (30.2) | NA | NA | NA | NA |
| 60 mg BID | 5 | 5861.3 (29.2) | 1.13 (0.98, 1.97) | 38135.6 (29.6) | 47099.9 (30.4) | NA | NA | NA | NA |
Data are presented as geometric mean (geometric coefficient of variation [CV]%), unless otherwise indicated.
Single‐dose assessments were made on Cycle 1 Days 1, 2, and 3. Steady‐state assessments were made on Cycle 1 Day 10.
Abbreviations: AUC, area under the plasma concentration‐time curve from time of drug administration to time (9 or 12 hours) or to infinity; BID, twice daily; CL/F, apparent clearance; Cmax, maximum observed plasma concentration; NA, not assessed; t1/2, elimination half‐life; Tmax, time to reach Cmax; Vz/F, apparent volume of distribution during terminal phase.
Data presented as median (range).
Data presented as geometric mean (range).