Table 5.
Effect of Food Intake on Brensocatib PK (Food Effect Population)
| Parameter | Fed | Fasted | GMR, % (90% CI) |
|---|---|---|---|
| Japanese, n=9 | |||
| Cmax, ng/mL | 293.0 | 355.8 | 82.4 (67.9‐99.9) |
| AUClast, ng ‧ h/mL | 4840.2 | 4918.9 | 98.4 (94.4‐102.5) |
| AUC∞, ng ‧ h/mL | 5232.0 | 5274.0 | 99.2 (95.7‐102.8) |
| White, n=10 | |||
| Cmax, ng/mL | 272.2 | 268.9 | 101.2 (81.4‐125.9) |
| AUClast, ng ‧ h/mL | 5214.2 | 5146.6 | 101.3 (96.8‐106.0) |
| AUC∞, ng ‧ h/mL | 6177.7 | 6201.2 | 99.6 (94.6‐104.9) |
AUC∞, area under the plasma concentration–time curve from time 0 to infinity; AUClast, area under the plasma concentration–time curve from time 0 to the last time with quantifiable concentration; Cmax, maximum plasma concentration; GMR, geometric mean ratio (fed/fasted); PK, pharmacokinetic.
PK values are expressed as least squares mean.