Table 2.
Pharmacokinetics of intravenous ITPP administration per cohort.
| Cohort (Single dose) | Cmin [mg/L] | Cmax [mg/L] | Tmax [h] | Clast [mg/L] | Tlast [h] | Half life/T0.5 [h] | Elimination rate λz [/h] | AUC [h*mg/L] | AUMC [h2*mg/L] | MRT [h] | CL [L/h] | VSS [L] |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 (1866 mg/m2) | 0.0 | 47.2 | 6.0 | 19.2 | 10.0 | 1.3 | 0.5 | 350.7 | 1994.7 | 1.7 | 4.8 | 11.0 |
| 2 (3732 mg/m2) | 0.0 | 120.6 | 6.0 | 55.8 | 10.0 | 1.8 | 0.4 | 847.4 | 4925.6 | 1.8 | 3.8 | 10.5 |
| 3 (5600 mg/m2) | 0.0 | 153.4 | 6.0 | 59.5 | 10.0 | 1.4 | 0.5 | 1168.7 | 6445.9 | 1.5 | 4.4 | 9.2 |
| 4 (7000 mg/m2) | 0.0 | 228.0 | 6.0 | 127.5 | 10.0 | 3.3 | 0.2 | 1649.5 | 9421.8 | 1.7 | 3.1 | 12.8 |
| 5 (8750 mg/m2) | 0.0 | 257.8 | 6.0 | 116.8 | 10.0 | 2.1 | 0.3 | 1850.5 | 10396.4 | 1.6 | 4.0 | 11.1 |
| 6 (10500 mg/m2) | 0.0 | 313.4 | 6.0 | 186.4 | 10.0 | 2.6 | 0.3 | 2439.2 | 13886.7 | 1.7 | 3.3 | 11.7 |
| 7 (12390 mg/m2) | 0.0 | 353.6 | 6.0 | 149.4 | 10.0 | 1.7 | 0.4 | 2457.2 | 14095.2 | 1.7 | 4.4 | 11.4 |
| 8 (14500 mg/m2) | 0.0 | 439.2 | 6.0 | 166.0 | 10.0 | 1.8 | 0.4 | 2864.1 | 16280.4 | 1.7 | 4.4 | 11.4 |
Cmin [mg/L] = minimal concentration at start of infusion; Cmax [mg/L] = maximum concentration; Tmax [h] = time of maximum concentration; Clast [mg/L] = last positive concentration observed; Tlast [h] = time of last positive concentration; Half-life / T0.5 [h] = half-life by lambda z = ln(2)/λz; Elimination rate λz [/h] = lambda z, negative of best fit terminal slope; AUC [h*mg/L] = Area under the curve from 0 to Tlast; AUMC [h2*mg/L] = Area under the first moment curve to the Tlast; MRT [h] = mean residence time; CL [L/h] = clearance; VSS [L] = volume of distribution at steady state