Table 3.
Statistical comparison of key adavosertib PK parameters in the fed and fasted treatment groups
| Parameter | Fed (n = 25) | Fasted (n = 28) | Fed/fasted ratio | |
|---|---|---|---|---|
| Geometric LS mean | Ratio | 90% CI | ||
| AUC (nM h) | 14,610 | 15,620 | 0.9353 | 0.8541–1.0243 |
| AUC0–t (nM h) | 14,260 | 15,370 | 0.9276 | 0.8442–1.0193 |
| Cmax (nM) | 988.7 | 1172 | 0.8434 | 0.7538–0.9436 |
| Parameter | Median | Fed/fasted comparison | ||
|---|---|---|---|---|
| Difference | 90% CI | |||
| tmax (h) | 5.95 | 3.01 | 1.97a | 1.03–2.58 |
Results for AUC, AUC0–t and Cmax are based on the linear mixed-effects model, with sequence, period, and treatment as fixed effects and subject nested within sequence as a random effect. Treatment group medians for tmax are based on all patients with tmax estimates in the respective treatment group. Median differences and CIs were calculated using the Hodges–Lehmann estimator. P values for treatment group difference in median tmax were calculated using the Wilcoxon signed rank test
aP = 0.0009