Table 3.
MEDI3902 PK parameters
| PK parameter | MEDI3902 500 mg (N = 16) | MEDI3902 1500 mg (N = 85) | ||
|---|---|---|---|---|
| n | Mean (SD) | n | Mean (SD) | |
| Serum | ||||
| Cmax, µg/mL | 16 | 87.6 (23.9) | 84 | 299 (94.1) |
| C21, µg/mL | 14 | 2.56 (2.23) | 72 | 9.46 (7.91) |
| AUC0–21, day*µg/mL | 16 | 418 (126) | 81 | 1410 (599) |
| AUC∞, day*µg/mL | 16 | 440 (135) | 81 | 1510 (675) |
| CL, L/day | 16 | 1.31 (0.64) | 81 | 1.27 (0.86) |
| t½, day | 16 | 6.56 (4.03) | 81 | 5.65 (2.69) |
| n/N | % | n/N | % | |
|---|---|---|---|---|
| Subjects with serum MEDI3902 levels > target level of 1.7 µg/mL on day 21 | 7/14 | 50.0% | 58/72 | 80.6% |
| Endotracheal aspirate† | ||||
| Cmax, µg/mL | – | – | n/a | 0.083 |
| AUC0–21, day*µg/mL | – | – | n/a | 0.704 |
| AUC∞, day*µg/mL | – | – | n/a | 0.784 |
| t½, day | – | – | n/a | 6.3 |
AUC0–21 = the area under the concentration–time curve from time zero to 21 days post-dose. AUC∞ = the area under the concentration–time curve from zero to infinity. CL = clearance. Cmax = maximum observed concentration. C21 = concentration 21 days post-dose. IV = intravenous. n/a = not applicable. SD = standard deviation. t½ = half-life
†Due to the large variability in measured endotracheal aspirate concentrations and limited samples per subject, it was not plausible to calculate endotracheal aspirate PK parameter at an individual level. Therefore, endotracheal aspirate PK parameters were calculated based on geometric mean concentration–time profile