TABLE 2.
Comparison of popPK model-based exposures among participants with ABSSSIsa
| Population | Participants (n) | GMb (95% CI) of: |
|||
|---|---|---|---|---|---|
| AUC0–24h_day1 (μg·h/ml) | AUC0–24h_last (μg·h/ml) | Cmax 0–24h_day1 (μg/ml) | Cmax 0–24h_last (μg/ml) | ||
| Adultc | 830 | 22.4 (21.9, 22.9) | 21.0 (20.4, 21.5) | 1.81 (1.73, 1.90) | 2.00 (1.94, 2.06) |
| Adolescentd | 91 | 26.6 (24.9, 28.4) | 28.6 (26.6, 30.8) | 2.61 (2.27, 3.01) | 3.13 (2.89, 3.38) |
a
popPK, population pharmacokinetics; 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
Participants aged ≥18 years with ABSSSIs who received 200 mg of tedizolid phosphate in the previous phase 2 and 3 trials.
d
Participants aged ≥12 years in the phase 3 clinical trial (PN012).