Table 2.
Blood Pharmacokinetic Parameters of Alisertib
| Median (Range) | ||||
|---|---|---|---|---|
| PK Parameters | Days | Liquid (n = 22) | ECT (n = 8) | Liquid vs ECT P-Valuea |
| CMAX (µM) | 1 | 10.8 (4.6–20.8) | 5.9 (1.0–9.7) | .0014 |
| 7 | 9.2 (1.3–23.1) | 5.7 (1.0–18.6) | ||
| TMAX (h) | 1 | 1.0 (0.5–4.0) | 5.0 (1.5–6.0) | <.0001 |
| 7 | 1.5 (1.5–4.0) | 4.0 (1.5–4.0) | ||
| AUC0-T (h·µM) | 1 | 57.8 (29.7–110) | 66.0 (48.9–91.2) | .41 |
| 7 | 83.8 (17.0–261) | 89.8 (20.2–143) | ||
| CL/F (L/h/m2) | 1 | 2.0 (1.1–3.9) | 2.3 (1.7–3.4) | .27 |
| 7 | 1.2 (0.4–6.0) | 1.0 (0.5–2.8) | ||
Abbreviations: AUC0-T, area under the concentration curve from 0 to infinity for Day 1 and from 0 to 24 h for Day 7; CMAX, maximum concentration; CL/F, apparent oral clearance; ECT, enteric-coated tablets; PK, pharmacokinetic; TMAX, time to reach CMAX.
aMann–Whitney tests based on Day 1 PK parameters.