TABLE 2.
| Study 1, N = 9 Parameter |
IV infusion | Oral | |||||||
|---|---|---|---|---|---|---|---|---|---|
| 2 × 1,000 mg | 600 mg | 800 mg | |||||||
| Day 1 | Day 4 | Day 7 | Day 8 | Day 14 | Day 21 | Day 28 | Day 35 | Day 42 | |
| Cmax (ng/mL) | 15,564 [28.7] | 13,237 [24.7] | 12,526[17.7] | 13,895 [13.8] | 14,831 [14.5] | 14,736[21.3] | 15,708 [14.4] | 15,722[13.2] | 15,383 [17.6] |
| AUC0-24 (ng·h/mL) | 197,821 [35.1] | 201,881 [22.6] | 194,912 [20.5] | 208,036 [16.9] | 223,610 [12.5] | – | – | – | 224,285 [16.8] |
| t½ (h) | – | – | – | – | – | – | – | – | 49.6 [39.3] |
| Tmax (h) | 12.0 [12.0–12.0] |
3.05 [3.00–3.08] |
3.03 [2.00–3.50] |
4.00 [2.00–8.00] |
3.02 [2.00–5.00] |
4.00 [2.00–4.00] |
4.00 [2.00–4.00] |
4.00 [2.00–4.00] |
3.50 [3.00–5.00] |
| CL (mL/h/kg) | – | – | 39.0 [15.8] | – | – | – | – | – | 34.6 [13.6] |
| Vz (L/kg) | – | – | – | – | – | – | – | – | 2.47 [38.6] |
a
Data are presented as geometric mean [geometric %CV].
b
Dash denotes that the parameter was not applicable to the study day.
c
AUC0-24, area under the concentration-time curve from time zero to 24 h postdose; AUC0-t, area under the concentration-time curve from zero to time t postdose; Cmax, maximum plasma concentration; %CV, percent coefficient of variation; CL, clearance; IV, intravenous; t1/2, terminal phase half-life; FMGX, fosmanogepix; MGX, manogepix; Tmax, time to maximum plasma concentration (Cmax); Vz, volume of distribution.