PK parameters after a single dose of rIX-FP and previous FIX product according to noncompartmental analysis
| Parameter (unit) baseline-corrected . | rIX-FP . | Previous FIX . | |||
|---|---|---|---|---|---|
| 25 IU/kg (n = 7) . | 50 IU/kg (n = 13) . | 75 IU/kg (n = 8) . | rFIX (n = 8) . | pdFIX (n = 4) . | |
| AUC0-inf, h × IU/dL | |||||
| Mean | 4192.42 | 7089.87 | 8995.24 | 976.76 | 1086.55 |
| SD | 1627.90 | 1622.83 | 1757.80 | 164.82 | 207.65 |
| Cmax, IU/dL | |||||
| Mean | 41.14 | 69.28 | 82.04 | 47.26 | 54.80 |
| SD | 5.33 | 13.00 | 14.27 | 11.90 | 9.89 |
| IR, IU/dL per IU/kg | |||||
| Mean | 1.653 | 1.376 | 1.084 | 0.945 | 1.096 |
| SD | 0.19 | 0.28 | 0.19 | 0.24 | 0.20 |
| Half-life, h | |||||
| Mean | 104.71 | 91.57 | 98.82 | 17.23 | 14.59 |
| SD | 55.08 | 20.74 | 17.48 | 2.28 | 1.73 |
| CL, mL/h per kg | |||||
| Mean | 0.73 | 0.75 | 0.87 | 5.24 | 4.76 |
| SD | 0.46 | 0.19 | 0.17 | 0.85 | 1.08 |
| Vz, mL/kg | |||||
| Mean | 91.6 | 95.0 | 123.1 | 130.6 | 98.7 |
| SD | 43.5 | 20.3 | 28.3 | 29.9 | 14.9 |
| Vss, mL/kg | |||||
| Mean | 85.4 | 91.6 | 119.4 | 132.5 | 99.1 |
| SD | 24.2 | 15.0 | 27.0 | 34.1 | 15.5 |
| MRT, h | |||||
| Mean | 136.00 | 127.03 | 138.13 | 25.13 | 21.13 |
| SD | 47.27 | 22.66 | 20.69 | 3.72 | 2.49 |
| Parameter (unit) baseline-corrected . | rIX-FP . | Previous FIX . | |||
|---|---|---|---|---|---|
| 25 IU/kg (n = 7) . | 50 IU/kg (n = 13) . | 75 IU/kg (n = 8) . | rFIX (n = 8) . | pdFIX (n = 4) . | |
| AUC0-inf, h × IU/dL | |||||
| Mean | 4192.42 | 7089.87 | 8995.24 | 976.76 | 1086.55 |
| SD | 1627.90 | 1622.83 | 1757.80 | 164.82 | 207.65 |
| Cmax, IU/dL | |||||
| Mean | 41.14 | 69.28 | 82.04 | 47.26 | 54.80 |
| SD | 5.33 | 13.00 | 14.27 | 11.90 | 9.89 |
| IR, IU/dL per IU/kg | |||||
| Mean | 1.653 | 1.376 | 1.084 | 0.945 | 1.096 |
| SD | 0.19 | 0.28 | 0.19 | 0.24 | 0.20 |
| Half-life, h | |||||
| Mean | 104.71 | 91.57 | 98.82 | 17.23 | 14.59 |
| SD | 55.08 | 20.74 | 17.48 | 2.28 | 1.73 |
| CL, mL/h per kg | |||||
| Mean | 0.73 | 0.75 | 0.87 | 5.24 | 4.76 |
| SD | 0.46 | 0.19 | 0.17 | 0.85 | 1.08 |
| Vz, mL/kg | |||||
| Mean | 91.6 | 95.0 | 123.1 | 130.6 | 98.7 |
| SD | 43.5 | 20.3 | 28.3 | 29.9 | 14.9 |
| Vss, mL/kg | |||||
| Mean | 85.4 | 91.6 | 119.4 | 132.5 | 99.1 |
| SD | 24.2 | 15.0 | 27.0 | 34.1 | 15.5 |
| MRT, h | |||||
| Mean | 136.00 | 127.03 | 138.13 | 25.13 | 21.13 |
| SD | 47.27 | 22.66 | 20.69 | 3.72 | 2.49 |
n indicates number of subjects; AUC0-inf, area under the curve from the time of dosing extrapolated to infinity, based on the last observed FIX concentration; Cmax, maximum observed FIX concentration; IR, incremental recovery according to the formula C30 minutes (IU/dL)/dose (IU/kg); CL, plasma clearance; Vz, volume of distribution based on the t1/2, normalized to body weight; Vss, volume of distribution at steady state, normalized to body weight; and MRT, mean residence time extrapolated to infinity.