TABLE 3.
GDC‐0334 dose proportionality assessment (geometric means) in humans
Fasted state | 75 mg (n = 6) | 200 mg (n = 6) | 300 mg (n = 12) | 600 mg (n = 6) | Β (90% CI) |
---|---|---|---|---|---|
Cmax (ng/ml) | 81.5 | 155 | 321 | 499 | 0.92 (0.75–109) |
AUC0–24 h (ng•h/mL) | 875 | 2100 | 4200 | 5640 | 0.96 (0.81–1.10) |
AUC0–72 h (ng•h/ml) | 1750 | 5130 | 8420 | 11,900 | 0.97 (0.83–1.10) |
Abbreviations: AUC0–24 h, area under the plasma concentration‐time curve from time 0 to 24 h; AUC0–72 h, area under the plasma concentration‐time curve from time 0 to 72 h, used for dose‐escalation decisions; CI, confidence interval; Cmax, maximum (peak) plasma drug concentration.