Table 8.
Pharmacokinetic parameters of SET-M33 on day 1 and day 28 of 4 weeks of daily intravenous (infusion) administration to male and female beagle dogs at 0.5, 1.5 and 4.0 mg/kg/day (group mean values ± standard deviation of Cmax and AUC0-24).
| Time | Parameters | Units | 0.5 mg/kg/day | 1.5 mg/kg/day | 4 mg/kg/day | |||
|---|---|---|---|---|---|---|---|---|
| Male | Female | Male | Female | Male | Female | |||
| Day 1 | tmax | minutes | EOI | EOI | EOI | EOI | EOI | EOI |
| tlast | minutes | EOI | 5 | 15 | 15 | 60 | 180 | |
| Cmax | ng/mL | 82.4 ± 22.4 | 82.8 ± 19.1 | 274 ± 110 | 345 ± 87 | 816 ± 188 | 1360 ± 220 | |
| AUC0-24 | ng ∙ h/mL | 42.2 ± 13.3 | 45.6 ± 10.4 | 157 ± 60 | 196 ± 48 | 569 ± 99 | 991 ± 161 | |
| Day 28 | tmax | minutes | EOI | EOI | EOI | EOI | EOI | EOI |
| tlast | minutes | 10 | 10 | 60 | 60 | 180 | 360 | |
| Cmax | ng/mL | 149 ± 16 | 125 ± 35 | 470 ± 218 | 645 ± 121 | 1490 ± 440 | 1930 ± 350 | |
| AUC0-24 | ng ∙ h/mL | 83.0 ± 9.8 | 76.5 ± 25.2 | 416 ± 209 | 402 ± 104 | 1050 ± 150 | 1550 ± 450 | |
AUC0-24 area under the plasma concentration–time curve in 24-h dosing intervals, Cmax maximum plasma concentrations, EOI end of infusion, tlast time point of the last quantifiable plasma concentration, tmax time at which Cmax occurred. Statistical analysis is not applicable to these experiments.