Table 2.
Summary of pharmacokinetic parameters of ensitrelvir for each renal function group
| Renal function group | ||||
|---|---|---|---|---|
| Parameter | Normal function | Mild impairment | Moderate impairment | Severe impairment |
| N | 8 | 8 | 8 | 8 |
| Cmax (μg/ml) | 15.5 (34.7) | 20.5 (18.9) | 20.5 (12.6) | 17.2 (19.8) |
| Tmax (h)a | 4.25 (2.00, 8.00) | 2.25 (1.50, 8.00) | 2.50 (1.00, 12.0) | 2.75 (2.00, 6.00) |
| AUC0–last (μg·h/ml) | 977.3 (25.9) | 1398 (20.7) | 1445 (24.5) | 1512 (23.4) |
| AUC0–inf (μg·h/ml) | 996.0 (26.0) | 1432 (20.8) | 1483 (26.0) | 1596 (26.1) |
| t1/2,z (h) | 44.0 (27.3) | 52.1 (30.1) | 54.7 (25.9) | 70.7 (28.5) |
| λz (1/h) | 0.0158 (27.3) | 0.0133 (30.1) | 0.0127 (25.9) | 0.0098 (28.5) |
| MRT (h) | 69.0 (20.7) | 80.8 (21.8) | 87.5 (21.7) | 105 (27.5) |
| CL/F (L/h) | 0.376 (26.0) | 0.262 (20.8) | 0.253 (26.0) | 0.235 (26.1) |
| Vz/F (l) | 23.9 (27.6) | 19.7 (35.7) | 19.9 (22.7) | 24.0 (22.7) |
| Ae (mg) | 54.8 (29.5) | 45.7 (44.7) | 58.6 (20.6) | 49.2 (26.5) |
| Feu (%) | 14.6 (29.5) | 12.2 (44.7) | 15.6 (20.6) | 13.1 (26.5) |
| CLR (l/h) | 0.0561 (17.2) | 0.0327 (44.7) | 0.0406 (29.1) | 0.0325 (18.3) |
Geometric mean (coefficient of variation % for geometric mean)
aMedian (Minimum, Maximum)