Table IV.
Pharmacokinetic Parameter | Dose Level 2.4 mg/m2 | Dose Level 3.2 mg/m2 | ||
---|---|---|---|---|
Day 1 (n=12) | Day 8 (n=12) | Day 1 (n=6) | Day 8 (n=5) | |
Tmax (h) | 2.0 (1.0–4.0) | 1.5 (0–4.0) | 2.0 (1.0–4.0) | 2.0 (1.1–4.0) |
Cmax (ng/mL) | 23.8 (2.5–55.6) | 47.4 (4.5–92.6) | 38.0 (16.3–58.1) | 41.5 (15.5–76.5) |
Half life (h) | 2.2 (0.7–5.2) | 2.5 (0.9–631.5) | 2.6 (1.1–3.2) | 1.8 (1.1–4.3) |
AUC0–8h (h•ng/mL) | 91.0 (10.7–264.1) | 146.7 (8.9–372.7) | 134.3 (59.0–236.0) | 139.9 (54.9–349.1) |
Accumulation (AUC Day8/Day1) | 1.7 (0.3–4.7) | 1.8 (0.4–2.5) | ||
Cl/F (L/h) | 28.0 (9.8–230.1) | 32.6 (14.2–65.2) | ||
Cl/m2 (L/h/m2) | 21.4 (6.0–230.1) | 19.9 (11.4–61.5) | ||
V/F (L) | 74.9 (43.6–888.7) | 99.4 (48.9–150.6) | ||
V/m2 (L/m2) | 67.4 (39.1–888.7) | 65.5 (39.1–101.6) |