TABLE 4.
Plasma pharmacokinetic parameters of GSK3036656 after repeat-dose administration
| Parametera | Treatment regimen (part B) | Visit | No. of subjects | Value |
|---|---|---|---|---|
| Geometric mean AUC0–t (h · ng/ml) (%CVb) | Repeat 5 mg | Period 1 day 1 | 7 | 485.6 (12.3) |
| Repeat 15 mg | Period 2 day 1 | 8 | 1,891.0 (9.9) | |
| Geometric mean AUC0–τ (h · ng/ml) (%CVb) | Repeat 5 mg | Period 1 day 14 | 7 | 1,392.2 (12.5) |
| Repeat 15 mg | Period 2 day 14 | 8 | 4,461.3 (23.7) | |
| Geometric mean Cmax (ng/ml) (%CVb) | Repeat 5 mg | Period 1 day 1 | 7 | 48.4 (33.6) |
| Period 1 day 14 | 7 | 97.0 (19.8) | ||
| Repeat 15 mg | Period 2 day 1 | 8 | 178.8 (32.8) | |
| Period 2 day 14 | 8 | 309.6 (20.2) | ||
| Geometric mean Rob (%CVb) | Repeat 5 mg | Period 1 day 14 | 7 | 2.9 (9.1) |
| Repeat 15 mg | Period 2 day 14 | 8 | 2.4 (21.6) | |
| Geometric mean RoCmaxc (%CV) | Repeat 5 mg | Period 1 day 14 | 7 | 2.0 (24.3) |
| Repeat 15 mg | Period 2 day 14 | 8 | 1.7 (26.7) | |
| Mean t1/2 (h) (SD) | Repeat 5 mg | Period 1 day 14 | 7 | 44.0 (11.4) |
| Repeat 15 mg | Period 2 day 14 | 8 | 37.0 (9.2) | |
| Mean Tmax (h) (SD) | Repeat 5 mg | Period 1 day 1 | 7 | 1.3 (0.9) |
| Period 1 day 14 | 7 | 0.8 (0.3) | ||
| Repeat 15 mg | Period 2 day 1 | 8 | 0.8 (0.3) | |
| Period 2 day 14 | 8 | 0.8 (0.3) | ||
a
%CVb, percent coefficient of variance between subjects.
b
Ro was calculated as day 14 AUC0–τ/day 1 AUC0–t, where t and τ equal 24 h.
c
RoCmax was calculated as day 14 Cmax/day 1 Cmax.