Table 3.
Summary of steady-state aztreonam and avibactam PK parameters following IV infusion of aztreonam/avibactam
| PK parameter | Cohort 1 (n = 16) | Cohort 2 + 3 (n = 18) |
|---|---|---|
| Aztreonam | ||
| AUC0–6 (μg·h/mL) | ||
| n | 13 | 8 |
| geometric mean | 235.2 | 234.7 |
| CV (%) | 60.6 | 54.6 |
| C max (μg/mL) | ||
| n | 13 | 8 |
| geometric mean | 62.5 | 55.4 |
| CV (%) | 146.9 | 42.6 |
| T max (h) | ||
| n | 13 | 8 |
| median | 2.9 | 2.4 |
| (min–max) | 0.5–3.5 | 2.0–3.0 |
| t ½ (h) | ||
| n | 11 | 8 |
| mean (SD) | 2.3 (1.06) | 2.8 (2.05) |
| CL (L/h) | ||
| n | 13 | 8 |
| geometric mean | 6.4 | 6.4 |
| CV (%) | 35.4 | 35.5 |
| V ss (L) | ||
| n | 11 | 8 |
| geometric mean | 20.3 | 19.6 |
| CV (%) | 16.9 | 31.8 |
| V z (L) | ||
| n | 11 | 8 |
| geometric mean | 21.4 | 21.6 |
| CV (%) | 15.3 | 24.1 |
| Avibactam | ||
| AUC0–6 (μg·h/mL) | ||
| n | 13 | 8 |
| geometric mean | 40.4 | 47.5 |
| CV (%) | 74.0 | 79.2 |
| C max (μg/mL) | ||
| n | 13 | 8 |
| geometric mean | 11.6 | 12.1 |
| CV (%) | 164.5 | 61.2 |
| T max (h) | ||
| n | 13 | 8 |
| median (min–max) | 2.9 (0.5–3.8) | 2.8 (2.0–3.3) |
| t ½ (h) | ||
| n | 11 | 8 |
| mean (SD) | 1.8 (0.59) | 2.2 (1.85) |
| CL (L/h) | ||
| n | 13 | 8 |
| geometric mean | 10.1 | 10.5 |
| CV (%) | 42.6 | 41.4 |
| V ss (L) | ||
| n | 11 | 8 |
| geometric mean | 26.0 | 23.7 |
| CV (%) | 22.0 | 29.7 |
| V z (L) | ||
| n | 11 | 8 |
| geometric mean | 28.2 | 27.4 |
| CV (%) | 20.4 | 20.6 |
V z, volume of distribution during the terminal phase after IV administration.