Table 3.
Mean pharmacokinetic parameters for FVIII and N8-GP in mice, rats, rabbits, and monkeys
| Animal species | FVIII compound | t1/2 (h) | CL (mL/kg per h) | MRT (h) |
|---|---|---|---|---|
| Normal mice (C57BL/6) | FVIII* | 2.5 | 36 | 3.6 |
| N8-GP | 6.8 | 15 | 8.8 | |
| Rats | FVIII* | 5.8 | 9.4 | 7.3 |
| N8-GP | 7.9 | 5.4 | 11 | |
| Rabbits | FVIII* | 7.8 | 4.8 | 10 |
| N8-GP | 14 | 2.8 | 21 | |
| Cynomolgus monkeys | FVIII* | 8.3 | 5.4 | ND |
| N8-GP | 18 | 1.5 | 25 |
ND, not determined.
*
ReFacto was used in normal mice, rats, and rabbits, whereas turoctocog alfa was used in cynomolgus monkeys. Values are based on analysis of FVIII antigen except for cynomolgus monkeys dosed FVIII, where a chromogenic assay was used.