Table 2.
Noncompartmental average pharmacokinetic parameters: CAT-354 administered s.c. or i.v.
| Treatment group | |||
|---|---|---|---|
| 150 mg i.v. | 150 mg s.c. | 300 mg s.c. | |
| Number of subjects | 10 | 10 | 10 |
| Cmax (µg ml−1) | 58.3 ± 14.4 | 17.1 ± 5.91 | 36.6 ± 13.1 |
| Cmax/D (µg ml−1 mg−1) | 0.389 ± 0.096 | 0.114 ± 0.039 | 0.122 ± 0.044 |
| tmax median (min, max) (days) | 0.063 (0.042, 1.02) | 5 (3, 9) | 5 (3, 9) |
| AUC(0,56 days) (µg ml−1 day) | 765 ± 220 | 467 ± 122 | 881 ± 287 |
| AUC(0,∞) (µg ml−1 day) | 903 ± 291 | 548 ± 143 | 1080 ± 315 |
| AUC extrapolated (%) | 14.3 ± 4.45 | 14.7 ± 4.98 | 18.2 ± 10.6 |
| AUC(0,∞)/D (µg ml−1 day mg−1) | 6.02 ± 1.94 | 3.66 ± 0.953 | 3.59 ± 1.05 |
| CL or CL/F (ml day−1) | 188 ± 84.0 | 292 ± 82.3 | 307 ± 109 |
| CL or CL/F (ml day−1 kg−1) | 2.40 ± 0.984 | 3.34 ± 0.828 | 3.60 ± 1.07 |
| VSS (ml) | 4960 ± 1440 | ND | ND |
| VSS (ml kg−1) | 63.6 ± 16.6 | ND | ND |
| t1/2 (days) | 21.4 ± 2.46 | 19.2 ± 3.1 | 19.4 ± 3.59 |
Averages are presented as mean ± SD except for tmax, which is presented as median (min, max); ND, not determined; Cmax, maximum observed concentration after infusion/injection; tmax, time at which Cmax is observed after infusion/injection; AUC(0,56 days), area under the serum concentration–time curve from time 0 to study day 56 (last observation); AUC(0,∞), area under the serum concentration–time curve from time 0 to infinity; CL or CL/F, systemic clearance; Vss, volume of distribution at steady state; t1/2, terminal phase elimination half-life.