Table 4.
Omaveloxolone pharmacokinetics
| Dose, mg | 2.5 | 5 | 10 | 15 | ||||
|---|---|---|---|---|---|---|---|---|
| Day | 1 | 28 | 1 | 28 | 1 | 28 | 1 | 28 |
| Evaluable (n) | 3 | 3 | 3 | 3 | 3 | 3* | 2** | n/a |
| AUC0–t (hours ng/mL) | ||||||||
| Mean | 27.6 | 44.8 | 31.6 | 63.7 | 114.4 | 188.3 | 183.5 | – |
| SD | 32.7 | 51.5 | 7.9 | 17.0 | 141.7 | 176.7 | 27.6 | – |
| Tmax (hours) | ||||||||
| Mean | 3.3 | 2.9 | 2.3 | 2.5 | 2.0 | 3.0 | 3.5 | – |
| SD | 2.1 | 1 | 0.6 | 1.2 | 1.5 | – | 2.8 | – |
| Cmax (ng/mL) | ||||||||
| Mean | 4.6 | 4.5 | 3.9 | 5.6 | 15.7 | 13.4 | 16.6 | – |
| SD | 7.8 | 4.6 | 2.1 | 1.8 | 34.5 | 9.7 | 6.9 | – |
| T1/2 (hours) | ||||||||
| Mean | 10.2 | 21.2 | 8.9 | 19.7 | 9.2 | 19.8 | 8.7 | – |
| SD | 2.4 | 20.1 | 1.3 | 8.1 | 0.6 | 4.1 | 3.7 | – |
Notes: Averages represent geometric mean.
*
One tube received broken at day 28.
**
Dose level completed in two subjects.
Abbreviations: AUC0–t, area under curve from time 0 to last; n/a, no samples available.