TABLE 3.
Exposure by weight quartile in adolescents with ABSSSIs in the phase 3 PN012 triala
| Body wt (kg) | Participants (n) | GM (95% CI) ofb: |
|||
|---|---|---|---|---|---|
| AUC0–24h_day1 (μg·h/ml) | AUC0–24h_last (μg·h/ml) | Cmax 0–24h_day1 (μg/ml) | Cmax 0–24h_last (μg/ml) | ||
| 27.6 to 46.5 | 23 | 32.2 (29.3, 35.4) | 32.4 (29.7, 35.4) | 3.32 (2.59, 4.25) | 3.87 (3.43, 4.37) |
| 46.5 to 57 | 23 | 29.6 (25.7, 34.0) | 32.2 (26.4, 39.4) | 3.83 (3.45, 4.25) | 3.54 (2.93, 4.29) |
| 57 to 70c | 24 | 25.5 (22.7, 28.7) | 27.9 (24.4, 32.0) | 2.52 (1.98, 3.20) | 2.97 (2.67, 3.30) |
| 70 to 126c | 21 | 20.1 (18.1, 22.3) | 22.6 (20.0, 25.7) | 1.38 (0.965, 1.96) | 2.29 (2.00, 2.63) |
a
ABSSSI, acute bacterial skin and skin structure infection.
b
AUC0–24h_day1, area under the concentration-time curve from 0 to 24 h on day 1; AUC0–24h_last, area under the concentration-time curve from 0 to 24 h on the last dosing day; Cmax 0–24h_day1, maximum concentration of drug in plasma from 0 to 24 h on day 1; Cmax 0–24h_last, maximum concentration of drug in plasma from 0 to 24 h on the last dosing day; GM, geometric mean.
c
The imbalanced group sizes were due to 4 participants with a body weight of 70 kg.