Table 6.
PK summary statistics stratified by renal function
| Parameter | Median (min–max) | P value | |
|---|---|---|---|
| Normal/mild | Moderate/severe | ||
| AUC on D1 | 129.0 (57.1–235.0) | 106.0 (69.1–193.0) | 0.576 |
| AUC on D2 | 150.0 (62.0–259.0) | 112.0 (70.6–218.0) | 0.149 |
| AUC on D3 | 132.0 (68.9–244.0) | 96.3 (79.4–198.0) | 0.172 |
| Average AUC on D1–2 | 136.0 (59.7–247.0) | 110.0 (70.0–205.0) | 0.287 |
| Average AUC on D1–3 | 140.0 (62.9–246.0) | 111.0 (73.1–203.0) | 0.287 |
| Average AUC on all days of therapy | 133 (73.7–235.0) | 100.0 (88.3–176.0) | 0.094 |
| CL (L/h) | 2.5 (1.8–3.9) | 3.5 (2.3–4.7) | 0.094 |
| t ½, α (h) | 1.4 (1.0–1.9) | 1.5 (1.0–2.7) | 0.488 |
| t ½, β (h) | 62.4 (18.3–127.0) | 47.2 (24.3–117.0) | 0.585 |
| V ss (L) | 192.0 (82.2–550.0) | 263 (88.3–541.0) | 0.799 |
AUC, area under the concentration-time curve; CL, clearance; t1/2 α, half-life for distribution phase; t1/2 β, half-life for elimination phase; Vss, volume of distribution at steady state.