Table 4. Full data on AUC0−∞, T1/2, Cmax and Tmax for SB939 at different dose levels.
|
Day 1
|
Day 3 or 5
|
|||||
|---|---|---|---|---|---|---|
| Dose level | Dose (mg) | Parameter | Mean | s.d. | Mean | s.d. |
| 1 | 10a | AUC0–∞ (ng h ml-1) | 126.7 | 23.9 | 147.3 | 32.6 |
| T1/2 (h) | 7.1 | 0.2 | 8.3 | 0.7 | ||
| Cmax (ng ml-1) | 14.6 | 6.0 | 18.3 | 6.4 | ||
| Tmax (h) | 2.5 | 0.9 | 1.3 | 0.3 | ||
| 2 | 10 | AUC0–∞ (ng h ml-1) | 137.2 | 26.6 | 187.7 | 32.7 |
| T1/2 (h) | 8.6 | 1.5 | 8.1 | 2.5 | ||
| Cmax (ng ml-1) | 19.5 | 8.1 | 23.3 | 11.4 | ||
| Tmax (h) | 1.1 | 0.6 | 1.3 | 0.6 | ||
| 3 | 20 | AUC0–∞ (ng h ml-1) | 243.7 | 117.1 | 424.0 | 235.4 |
| T1/2 (h) | 5.9 | 2.4 | 7.7 | 0.6 | ||
| Cmax (ng ml-1) | 45.9 | 28.5 | 51.3 | 31.9 | ||
| Tmax (h) | 1.5 | 0.9 | 1.6 | 0.8 | ||
| 4 | 30 | AUC0–∞ (ng h ml-1) | 383.8 | 131.8 | 544.5 | 206.3 |
| T1/2 (h) | 8.6 | 1.7 | 8.8 | 2.1 | ||
| Cmax (ng ml-1) | 55.8 | 21.7 | 74.3 | 28.9 | ||
| Tmax (h) | 1.8 | 0.9 | 1.6 | 0.5 | ||
| 5 | 50 | AUC0–∞ (ng h ml-1) | 661.3 | 415.3 | 793.7 | 11.2 |
| T1/2 (h) | 5.6 | 1.3 | 8.9 | 1.2 | ||
| Cmax (ng ml-1) | 124.1 | 93.5 | 101.3 | 5.6 | ||
| Tmax (h) | 1.6 | 1.0 | 1.7 | 0.3 | ||
| 5.5 | 60 | AUC0–∞ (ng h ml-1) | 1028.7 | 229.4 | 1625.2 | 405.5 |
| T1/2 (h) | 6.7 | 0.4 | 6.9 | 1.6 | ||
| Cmax (ng ml-1) | 209.6 | 55.3 | 262.5 | 65.9 | ||
| Tmax (h) | 1.2 | 0.5 | 1.3 | 0.4 | ||
| 6 | 70 | AUC0–∞ (ng h ml-1) | 1053.8 | 664.9 | 1134.3 | 678.0 |
| T1/2 (h) | 7.0 | 1.7 | 6.4 | 0.7 | ||
| Cmax (ng ml-1) | 178.2 | 122.2 | 159.7 | 118.8 | ||
| Tmax (h) | 1.6 | 0.4 | 1.5 | 0.5 | ||
| 7 | 90 | AUC0–∞ (ng h ml-1) | 1130.0 | 43.8 | 1229.0 | — |
| T1/2 (h) | 6.4 | 0.5 | 6.1 | — | ||
| Cmax (ng ml-1) | 228.9 | 7.1 | 116.0 | — | ||
| Tmax (h) | 1.0 | 0.0 | 1.5 | — | ||
3 days every 2 weeks.