Table 3.
Parameter Single Dose (Day 1) | Japanese n = 25 | White n = 24 | Ratio of Means (90% CI) for All Participants |
---|---|---|---|
Cmax, (ng/mL)/mg | 6.1 | 6.9 | 88.1 (74.7‐103.9) |
AUCτ, (ng ‧ h/mL)/mg | 62.5 | 75.4 | 82.9 (72.3‐95.1) |
AUClast, (ng ‧ h/mL)/mg | 94.0 | 118.8 | 79.2 (67.5‐92.8) |
AUC∞, (ng ‧ h/mL)/mg | 103.9 | 133.9 | 77.6 (65.1‐92.6) |
Multiple Dosing (Day 30) | n = 23 | n = 24 | |
---|---|---|---|
Cmax, (ng/mL)/mg | 8.5 | 10.6 | 80.9 (68.6‐95.3) |
AUCτ, (ng ‧ h/mL)/mg | 107.6 | 144.8 | 74.4 (60.3‐91.8) |
AUClast, (ng ‧ h/mL)/mg | 172.9 | 243.8 | 70.9 (55.8‐90.1) |
AUC∞, (ng ‧ h/mL)/mg | 194.9 | 285.4 | 68.3 (52.7‐88.6) |
AUC∞, area under the plasma concentration–time curve from time 0 to infinity; AUCτ, area under the plasma concentration–time curve over the dosing interval; AUClast, area under the plasma concentration–time curve from time 0 to the last time with quantifiable concentration; Cmax, maximum plasma concentration; PK, pharmacokinetic.
Data are expressed as geometric least squares mean.
Analysis based on data pooled from all 3 brensocatib dose groups.
The PK population for part A included 49 participants (25 Japanese, 24 White) who received brensocatib and had evaluable PK data.