Table 1.
Omaveloxolone PK parameters for cynomolgus monkeys
| Parameter (units)a | Day 1 | Day 28 | ||||
|---|---|---|---|---|---|---|
| Dose (mg/kg) | 10 | 30 | 100 | 10 | 30 | 100 |
| N | 5 | 5 | 5 | 5 | 5 | 5 |
| Tmax (hours) | 10 | 12 | 8 | 2 | 4 | 2 |
| Cmax (ng/mL) | 44.8±49.7 | 105±34 | 227±177 | 54.8±13.7 | 213±44 | 358±86 |
| AUC(0–24 h) (h×μg/mL) | 0.502±0.315 | 1.74±0.46 | 3.16±0.71 | 0.681±0.144 | 2.76±0.58 | 5.68±1.29 |
| AUC(0–24 h)/Dose ((h×μg/mL)/(mg/kg)) | 0.0502 | 0.0581 | 0.0316 | 0.0681 | 0.0918 | 0.0568 |
| D28 AUC/D1 AUC | – | – | – | 1.36 | 1.59 | 1.80 |
| T1/2z (hours) | 8.74±2.56 | 11.0±4.8 | 18.1±6.8 | 9.56±5.49 | 8.24±2.59 | 12.2±4.2 |
Notes:
a
PK parameter estimates were determined for each individual monkey and are presented as mean ± SD. Tmax data are presented as median.
Abbreviations: AUC, area under the curve; Cmax, maximum plasma concentration; D, day; PK, pharmacokinetic; T1/2, terminal half-life; Tmax, time to maximum plasma concentration.