Table 3.
Pharmacokinetic parameters after the first and fourth SCT400 infusions
| Infusion time | 250 mg/m2 (n=3) | 375 mg/m2 (n=9) | 500 mg/m2 (n=3) | |||
| 1st | 4th | 1st | 4th | 1st | 4th | |
| T1/2, terminal half-life; Tmax, time to maximum plasma concentration; Cmax, maximum concentration; AUC0→168, area under the concentration-time curve from time zero to 168 h after the end the infusion; AUC0→∞, area under the concentration-time curve from time zero to infinity; Vz, volume of distribution; CL, clearance; MRT, mean retention time. | ||||||
| t1/2 (h) | ||||||
| x±s | 83.0±56.9 | 191.5±135.3 | 122.5±46.7 | 197.0±75.0 | 140.9±21.5 | 240.4±130.0 |
| Median (range) | 100.9 (19.4-128.9) | 233.0 (40.4-301.3) | 133.1 (24.4-185.9) | 180.5 (50.3-280.5) | 130.9 (126.3-165.6) | 179.7 (151.9-389.6) |
| Tmax (h) | ||||||
| x±s | 7.5±0.5 | 5.3±1.5 | 6.4±1.2 | 4.5±0.7 | 7.5±1.1 | 5.5±0.2 |
| Median (range) | 7.5 (7.0-8.0) | 5.0 (4.0-7.0) | 7.0 (4.5-7.5) | 4.5 (3.0-5.4) | 8.1 (6.3-8.2) | 5.6 (5.4-5.7) |
| Cmax (μg/mL) | ||||||
| x±s | 125.7±22.4 | 172.0±51.5 | 200.6±20.2 | 339.1±71.0 | 265.3±11.9 | 465.4±38.7 |
| Median (range) | 137.2 (99.9-140.1) | 198.9 (112.6-204.5) | 190.7 (178.8-241.0) | 361.9 (198.2-423.1) | 269.0 (252.1-275.0) | 458.6 (430.7-507.1) |
| AUC0→168 (μg·h/mL) | ||||||
| x±s | 8,144.1±4,413.9 | 16,989.8±9,298.3 | 15,196.9±4,182.4 | 35,951.0±11,389.1 | 21,809.2±2,559.8 | 53,136.8±8,758.8 |
| Median (range) | 10,591.0 (3,048.7-10,792.7) |
21,789.3 (6,272.5-22,907.7) |
15,551.8 (5,352.7-19,232.1) |
37,750.4 (10,578.4-47,589.0) |
21,416.8 (19,468.2-24,542.5) |
55,532.0 (43,429.7-60,448.9) |
| AUC0→∞ (μg·h/mL) | ||||||
| x±s | 12,047.2±7,762.4 | 42,967.8±31,994.9 | 25,556.7±8,481.4 | 86,502.4±39,601.7 | 40,211.8±8,879.0 | 139,939.5±71,865.7 |
| Median (range) | 15,721.9 (3,129.8-17,290.0) |
55,349.5 (6,632.4-66,921.4) |
28,000.2 (5,411.2-33,866.6) |
88,807.7 (11,498.9-131,573.6) |
37,209.3 (33,223.3-50,202.8) |
117,182.2 (82,207.6-220,428.6) |
| Vz (mL) | ||||||
| x±s | 2,412.1±242.5 | 1,778.9±364.2 | 2,601.3±550.1 | 1,372.2±424.1 | 2,552.9±181.9 | 1,238.0±117.6 |
| Median (range) | 2,313.5 (2,234.5-2,688.4) |
1,623.8 (1,518.0-2,195.0) |
2,443.6 (1,971.0-3,486.6) |
1,187.7 (1,045.3-2,367.4) |
2,537.8 (2,378.9-2,741.9) |
1,275.0 (1,106.3-1,332.6) |
| CL (mL/h/m2) | ||||||
| x±s | 36.7±37.4 | 15.3±19.4 | 19.8±18.7 | 7.4±9.5 | 12.8±2.6 | 4.2±1.9 |
| Median (range) | 15.9 (14.5-79.9) | 4.5 (3.7-37.7) | 13.4 (11.1-69.3) | 4.2 (2.9-32.6) | 13.4 (10.0-15.1) | 4.3 (2.3-6.1) |
| MRT (h) | ||||||
| x±s | 52.5±22.4 | 66.6±15.5 | 64.1±11.7 | 71.8±8.6 | 68.5±2.0 | 75.0±3.0 |
| Median (range) | 65.5 (26.6-65.5) | 75.4 (48.8-75.8) | 67.6 (33.4-71.8) | 74.3 (49.3-76.7) | 67.8 (67.1-70.8) | 76.7 (71.6-76.8) |