Table 4.
Summary of serum PK parameters for CT-P63 (PK Set).
| CT-P63 600 mg (n = 6) | CT-P63 900 mg (n = 6) | CT-P63 1800 mg (n = 6) | |
|---|---|---|---|
| Cmax (μg/mL) | 191.3 (17.9) | 282.4 (11.7) | 482.8 (9.0) |
| Tmax (h), median (range) | 1.56 (1.08–13.08) | 1.59 (1.10–5.07) | 2.08 (1.10–13.07) |
| t½ (h) | 578.4 (21.0) | 643.3 (19.0) | 600.1 (20.9) |
| CL (mL/h) | 8.514 (29.2) | 8.674 (23.4) | 10.01 (21.6) |
| AUC0–inf (h*μg/mL) | 70470 (29.2) | 103800 (23.4) | 179900 (21.6) |
| AUC0–last (h*μg/mL) | 65020 (25.9) | 93790 (19.9) | 159700 (17.6)* |
| %AUCext (%) | 6.782 (67.4) | 8.836 (50.0) | 8.995 (71.5) |
| λz (1/h) | 0.001198 (21.0) | 0.001078 (19.0) | 0.001155 (20.9) |
| Vss (mL) | 6572 (12.4) | 7261 (12.4) | 8045 (5.6) |
| Dose-normalized | |||
| Cmax/dose (μg/mL/mg) | 0.3188 (17.9) | 0.3138 (11.7) | 0.2682 (9.0) |
| AUC0–inf/dose (h*μg/mL/mg) | 117.5 (29.2) | 115.3 (23.4) | 99.94 (21.6) |
| AUC0–last/dose (h*μg/mL/mg) | 108.4 (25.9) | 104.2 (19.9) | 88.70 (17.6)* |
Notes: All data are geometric mean (gCV%) unless otherwise stated.
AUC0–inf, area under the concentration–time curve from time zero to infinity; AUC0–last, area under the concentration–time curve from time zero to the last quantifiable concentration; %AUCext, percentage of AUC0–inf obtained by extrapolation; CL, total body clearance; Cmax, maximum serum concentration; EOS, end-of-study; gCV, geometric coefficient of variation; λz, terminal elimination rate constant; PK, pharmacokinetic; t½, terminal elimination half-life; Tmax, time to maximum serum concentration; Vss volume of distribution at steady state.
*One patient in the CT-P63 1800 mg group was excluded from AUC0–last and AUC0–last/dose calculations because they were lost to follow-up at EOS visit.