rFIXFc antigen PK parameters in 12 subjects with hemophilia B
| Dose (IU/kg) . | n . | Cmax, μg/mL . | AUCINF, h × μg/mL . | CL, mL/h/kg . | Vss, mL/kg . | MRT, h . | t1/2α, h . | t1/2β, h . |
|---|---|---|---|---|---|---|---|---|
| 12.5 | 1 | 1.67 | 91.3 | 2.50 | 245 | 98.2 | 21.2 | 107 |
| 25 | 1 | 2.73 | 144 | 3.14 | 273 | 87.1 | 11.3 | 71.0 |
| 50* | 5 | 7.51 ± 2.48 (5.47-11.7) | 408 ± 73.9 (348-531) | 2.28 ± 0.374 (1.71-2.67) | 259 ± 78.5 (184-366) | 112 ± 21.5 (84.5-144) | 13.1 ± 4.77 (10.1-18.6)† | 110 ± 26.5 (85.3-140) |
| 100 | 5 | 15.4 ± 3.96 (12.5-21.6) | 897 ± 206 (667-1200) | 2.11 ± 0.464 (1.51-2.72) | 238 ± 52.1 (156-295) | 114 ± 17.1 (96.8-137) | 12.1 ± 2.33 (10.6-15.7) | 95.8 ± 11.1 (78.0-107) |
| Mean ± SD for all dose groups | 12 | NA‡ | NA‡ | 2.30 ± 0.464 (15.1-3.14) | 250 ± 58.2 (156-366) | 110 ± 18.5 (84.5-144) | 13.2 ± 3.95 (9.79-21.2)† | 101 ± 20.9 (71.0-140) |
| Dose (IU/kg) . | n . | Cmax, μg/mL . | AUCINF, h × μg/mL . | CL, mL/h/kg . | Vss, mL/kg . | MRT, h . | t1/2α, h . | t1/2β, h . |
|---|---|---|---|---|---|---|---|---|
| 12.5 | 1 | 1.67 | 91.3 | 2.50 | 245 | 98.2 | 21.2 | 107 |
| 25 | 1 | 2.73 | 144 | 3.14 | 273 | 87.1 | 11.3 | 71.0 |
| 50* | 5 | 7.51 ± 2.48 (5.47-11.7) | 408 ± 73.9 (348-531) | 2.28 ± 0.374 (1.71-2.67) | 259 ± 78.5 (184-366) | 112 ± 21.5 (84.5-144) | 13.1 ± 4.77 (10.1-18.6)† | 110 ± 26.5 (85.3-140) |
| 100 | 5 | 15.4 ± 3.96 (12.5-21.6) | 897 ± 206 (667-1200) | 2.11 ± 0.464 (1.51-2.72) | 238 ± 52.1 (156-295) | 114 ± 17.1 (96.8-137) | 12.1 ± 2.33 (10.6-15.7) | 95.8 ± 11.1 (78.0-107) |
| Mean ± SD for all dose groups | 12 | NA‡ | NA‡ | 2.30 ± 0.464 (15.1-3.14) | 250 ± 58.2 (156-366) | 110 ± 18.5 (84.5-144) | 13.2 ± 3.95 (9.79-21.2)† | 101 ± 20.9 (71.0-140) |
Data are expressed as mean ± SD (range).
Cmax indicates maximum concentration; AUCINF, area under the curve (time zero extrapolated to infinite time); CL, clearance; Vss, volume of distribution at steady state; MRT, mean residence time; t1/2α, distribution t1/2; t1/2β, elimination t1/2; and NA, not applicable.
For 2 subjects in the 50-IU/kg dose group, data were inadequately described by the 2-compartment model; therefore, a noncompartmental analysis was used.
Not including 2 subjects whose PK parameters were determined by noncompartmental analysis.
Data are not applicable because parameters are not dose independent; thus, the mean and SD values were not calculated across the different dose groups.