Table 3.
Summary of CT900 plasma pharmacokinetic parameters from dose escalation phase, Cycle 1 Day 1.
| Cohort (mg/m2) | Descriptive statistic | T max (h) | C max (ng/mL) | HL Lambda_z (h) | AUC0-24 (h.ng/mL) | AUClast (h.ng/mL) | Cl (mL/h) | Vss (mL) |
|---|---|---|---|---|---|---|---|---|
| 1 | Mean | 1.0 | 402 | 6.7 | 1,654 | 1,654 | 1,219 | 7,594 |
| CV% | 1.7 | 7.2 | 47.6 | 39.7 | 39.7 | 47.7 | 19.7 | |
| Geometric Mean | 1.0 | 402 | 6.1 | 1,565 | 1,565 | 1,116 | 7,501 | |
| CV% Geo Mean | 1.8 | 7.2 | 62.2 | 43.4 | 43 | 57.6 | 19.0 | |
| Median | 1.0 | 401 | 7.5 | 1,618 | 1,618 | 1,250 | 6,745 | |
| Range | 1.0–1.0 | 374–432 | 3.2–9.4 | 1,017–2,329 | 1,017–2,329 | 623–1,784 | 6,712–9,324 | |
| N | 3 | 3 | 3 | 3 | 3 | 3 | 3 | |
| 2 | Mean | 0.9 | 746 | 12.6 | 4,892 | 6,857 | 674 | 8,519 |
| CV% | 29.6 | 14.4 | 42.1 | 42.9 | 63.0 | 75.1 | 34.2 | |
| Geometric Mean | 0.9 | 740 | 11.8 | 4,541 | 5,855 | 552 | 8,193 | |
| CV% Geo Mean | 37.1 | 14.9 | 41.9 | 48.2 | 75 | 82.6 | 32.1 | |
| Median | 1.0 | 759 | 11.3 | 4,733 | 6,046 | 523 | 7,407 | |
| Range | 0.5–1.1 | 613–855 | 7.5–20.0 | 2,516–7,588 | 2,516–12,818 | 244–1,405 | 6,534–12,730 | |
| N | 4 | 4 | 4 | 4 | 4 | 4 | 4 | |
| 6 | Mean | 1.0 | 2,030 | 19.9 | 15,104 | 25,574 | 460 | 12,024 |
| N | 1 | 1 | 1 | 1 | 1 | 1 | 1 | |
| 12 | Mean | 1.0 | 5,132 | 28.7 | 47,191 | 87,560 | 216 | 7,621 |
| CV% | 1.4 | 12.4 | 24.6 | 13.9 | 23.5 | 29.6 | 11.1 | |
| Geometric Mean | 1.0 | 5,101 | 28.1 | 46,862 | 85,858 | 207 | 7,586 | |
| CV% Geo Mean | 1.4 | 12.2 | 22.4 | 13.0 | 22 | 33.0 | 10.6 | |
| Median | 1.0 | 4,830 | 26.5 | 45,428 | 83,497 | 221 | 7,333 | |
| Range | 1.0–1.0 | 4,460–6,010 | 23.0–41.0 | 42,328–58,611 | 68,732–122,559 | 126–303 | 6,986–9,065 | |
| N | 5 | 5 | 5 | 5 | 5 | 5 | 5 |
Abbreviations: CV%, percentage coefficient of variation; Tmax, time to maximum observed plasma concentration; Cmax, maximum observed plasma concentration; HL λz, half-life terminal rate constant; AUC0-24, area under the plasma concentration versus time curve from 0 to 24 hours; AUClast, area under the plasma concentration versus time curve from 0 to the last value above the limit of quantification; Cl, clearance; Vss, steady state volume of distribution.