Table 2.
Summary of PK parameter estimates by cohort
| Dose (mg) | AUC (0-12) (ng*hr/mL) | AUC (0-inf) (ng*hr/mL) | Cmax (ng/mL) | Tmax (hours) | Half-Life (hours) | Clearance (L/hour) | Volume of Distribution (L) |
|---|---|---|---|---|---|---|---|
| Single-Dose Group | |||||||
| 100 | 5780.5 ± 2841.9 | 5904.6 ± 2797.1 | 1419.6 ± 648.4 | 4.0 ± 0 | 1.7 ± 0.4 | 19.3 ± 7.7 | 50.5 ± 26 |
| 200 | 9443.5 ± 1362.8 | 10798.9 ± 2074 | 1818.1 ± 544 | 6.7 ± 1.2 | 2.3 ± 0.9 | 19 ± 3.4 | 60.7 ± 17.8 |
| 300 | 14907.8 ± 9398.4 | 22796.3 ± 6943.3 | 2800.2 ± 1787.4 | 5.3 ± 1.2 | 5.9 ± 4.5 | 14.2 ± 5.2 | 122.6 ± 89.7 |
| 400 | 4518.7 ± 1858.9 | 6549.3 ± 5009 | 795.6 ± 220.3 | 7.3 ± 1.2 | 4.5 ± 4.5 | 86.6 ± 52.9 | 361.3 ± 125.4 |
| 800 | 20781.4 ± 9139.3 | 29923.4 ± 14118.9 | 3742.6 ± 1890.6 | 6.0 ± 2.0 | 4.5 ± 3.0 | 32.8 ± 19.6 | 177.6 ± 75.8 |
| 1600 | 7540.5 ± 7123.6 | 11490.6 ± 8760.1 | 1272.4 ± 1166.0 | 9.3 ± 2.3 | 2.4 ± 0.4 | 196.3 ± 149.6 | 624.9 ± 400.2 |
| Multiple-Dose Group | |||||||
| 100 | 1987.7 ± 741.2 | 2391.7 ± 496.7 | 493.3 ± 335.9 | 4.7 ± 1.2 | 3.8 ± 3.1 | 263.1 ± 271.7 | 43.2 ± 9.9 |
| 200 | 5083.1 ± 2488.0 | 5343.5 ± 2442.3 | 1026.8 ± 587.0 | 4.7 ± 1.2 | 2.1 ± 0.8 | 162.8 ± 158.7 | 45.8 ± 27.7 |
| 300 | 7374.5 ± 5337.9 | 9980.9 ± 5002.2 | 1816.8 ± 1332.4 | 6.0 ± 5.3 | 2.5 ± 1.2 | 141.1 ± 122.9 | 34.4 ± 17.2 |
| 400 | 7458.5 ± 4277.6 | 8110.9 ± 4589.6 | 1320.3 ± 707.3 | 7.3 ± 1.2 | 2.3 ± 0.3 | 218.5 ± 143.0 | 69.6 ± 54.8 |
| 800 | 8764.4 ± 6419.6 | 9559.1 ± 6221.8 | 1299.9 ± 945.2 | 6.7 ± 2.3 | 3.0 ± 1.8 | 559.2 ± 595.7 | 108.8 ± 60.8 |
| 1600 | 22171.2 ± 16485.0 | 60718.3 ± 79375.0 | 3746.0 ± 2338.5 | 6.7 ± 1.2 | 6.9 ± 7.7 | 353.8 ± 174.1 | 78.1 ± 62.9 |
Results are means ± SD. AUC, area under the curve; Cmax, maximum concentration; Tmax, time to maximum concentration.