Table 3 Noncompartmental pharmacokinetic parameters
Parameter | MEDI-546 | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
0.1 mg/kg single dose | 0.3 mg/kg single dose | 1.0 mg/kg single dose | 3.0 mg/kg single dose | 10.0 mg/kg single dose | 20.0 mg/kg single dose | 0.3 mg/kg/week multiple dose | 1.0 mg/kg/week multiple dose | 5.0 mg/kg/week multiple dose | ||||
1stdose | 4thdose | 1stdose | 4thdose | 1stdose | 4thdose | |||||||
Number of subjects | 1 | 4 | 4 | 4 | 4 | 4 | 4 | 4 | 4 | 4 | 5 | 3 |
Cmax, mean (SD), μg/mL | 1.97 (NA) | 6.69 (1.47) | 23.3 (2.22) | 72.4 (13.7) | 213 (44.0) | 394 (83.5) | 6.43 (0.470) | 6.32 (1.01) | 19.1 (7.80) | 35.8 (15.5) | 87.6 (19.3) | 135 (26.5) |
AUCa, mean (SD), μg · day/mL | 2.45 (NA) | 12.4 (4.91) | 102 (14.1) | 497 (105) | 2610 (728) | 4870 (1750) | NA | 10.7 (2.53) | NA | 159 (68.9) | NA | 849 (165) |
CL, mean (SD), mL/kg/day | 40.8 (NA) | 27.4 (11.0) | 9.94 (1.44) | 6.26 (1.43) | 4.07 (1.13) | 4.67 (2.18) | NA | NA | NA | NA | NA | NA |
t1/2, mean (SD), d | 0.84 (NA) | 1.24 (0.358) | 2.96 (0.593) | 4.07 (1.23) | 7.70 (2.26) | 11.8 (2.06) | NA | 1.06 (0.174) | NA | 4.94 (1.47) | NA | 6.28 (0.921) |