Table 2.
Summary of adavosertib PK parameters by treatment group (PK analysis set)
| Parameter | Fed (n = 25) | Fasted (n = 28) | ||||
|---|---|---|---|---|---|---|
| Mean (SD) | Geometric mean (CV, %) | Median (range) | Mean (SD) | Geometric mean (CV, %) | Median (range) | |
| AUC (nM h) | 15,140 (5783) | 14,080 (42.84) | 14,410 (3620–33,600) | 16,900 (4747) | 16,300 (27.65) | 17,370 (10,400–31,000) |
| AUC0–t (nM h) | 14,820 (5693) | 13,750 (44.06) | 13,980 (3390–32,600) | 16,640 (4737) | 16,040 (28.05) | 17,020 (10,400–30,800) |
| Cmax (nM) | 1012 (301) | 965.9 (33.00) | 1010 (390–1630) | 1244 (352.9) | 1192 (31.56) | 1260 (439–2120) |
| tmax (h) | ND | ND | 5.95 (2.93–8.12) | ND | ND | 3.01 (1.00–6.05) |
| t½ (h) | 12.29 (4.07) | ND | 11.67 (6.84–28.1) | 12.28 (3.708) | ND | 11.20 (7.54–25.7) |
| CL/F (L/h) | 46.05 (26.85) | ND | 40.85 (17.5–163) | 37.40 (10.08) | ND | 33.88 (19.0–56.5) |
| Vz/F (L) | 916.5 (1200) | ND | 640.0 (338–6590) | 670.3 (308.9) | ND | 578.4 (303–1660) |
CV coefficient of variation, ND not determined