Table 3.
Derived PK parameters [geometric mean (95% confidence interval)] after single dosing in the FTIH study
| Part 1 | |||||
|---|---|---|---|---|---|
| SB-705498 dose | |||||
| 0.5 mg | 1.5 mg | 3 mg | 6 mg | 12 mg | |
| n = 12 | n = 12 | n = 11 | n = 12 | n = 12 | |
| AUC(0,t) (ng ml−1 h) | NC | 152.8 (121.0, 193.0) | 249.8 (100.7, 619.4) | 440.6 (346.2, 560.9) | 903.6 (617.8, 321.7) |
| Cmax (ng ml−1) | 4.7 (3.3, 6.6) | 22.2 (18.2, 27.1) | 33.1 (20.1, 54.7) | 43.0 (33.5, 55.2) | 86.4 (64.4, 115.9) |
| tmax (h)* | 1.0 [0.5, 2.0] | 1.0 [1.0, 8.0] | 2.0 (0.25, 4.02) | 2.0 (1.00, 4.00) | 2.0 (1.00, 8.00) |
*
Presented as median [range]. AUC(0,t), area under the plasma concentration–time curve from time zero to time t; Cmax, maximum plasma concentration; NC, Non-calculable due to non-quantifiable concentrations; tmax, time to Cmax.