Summary of pharmacokinetic parameters
| Species/compound . | Dose, mg/kg (IU/kg) . | Cmax, ng/mL (IU/mL) . | Half-life, h . | Clearance, mL/h/kg . |
|---|---|---|---|---|
| HB mouse | ||||
| rFIX | 1.5 (375) | 8777 (1.70) | 17 (6*) | 36 (50*) |
| N9-GP | 1.5 (285) | 15 500 (1.78) | 41 (67) | 3.6 (4.8) |
| HB dog | ||||
| rFIX | 0.4 (100) | 3680 (0.98) | 25 (16) | 7 (9.8) |
| N9-GP | 0.4 (76) | 5130 (1.20) | 156 (113) | 0.6 (0.6) |
| Mini-pig | ||||
| rFIX | 0.2 (50) | 1850 (nd) | 16 (nd) | 12 (nd) |
| N9-GP | 0.2 (38) | 1993 (nd) | 76 (nd) | 1.7 (nd) |
| Species/compound . | Dose, mg/kg (IU/kg) . | Cmax, ng/mL (IU/mL) . | Half-life, h . | Clearance, mL/h/kg . |
|---|---|---|---|---|
| HB mouse | ||||
| rFIX | 1.5 (375) | 8777 (1.70) | 17 (6*) | 36 (50*) |
| N9-GP | 1.5 (285) | 15 500 (1.78) | 41 (67) | 3.6 (4.8) |
| HB dog | ||||
| rFIX | 0.4 (100) | 3680 (0.98) | 25 (16) | 7 (9.8) |
| N9-GP | 0.4 (76) | 5130 (1.20) | 156 (113) | 0.6 (0.6) |
| Mini-pig | ||||
| rFIX | 0.2 (50) | 1850 (nd) | 16 (nd) | 12 (nd) |
| N9-GP | 0.2 (38) | 1993 (nd) | 76 (nd) | 1.7 (nd) |
All compounds were administered intravenously. Noncompartmental parameters were estimated from plasma profiles obtained by Ag or aPTT clot activity (in parentheses) measurements.
rFIX indicates recombinant factor IX; and aPTT, activated partial thromboplastin time.
Based on few data points (0-16 hours) due to fast plasma elimination below detection limit of the assay.