Table 4.
Geometric mean (%CV) plasma pharmacokinetic parameters for total and free mifamurtide by hepatic function group
| Parameter, geometric mean (%CV) | Mild HI (n = 9) | Healthy match, mild HI (n = 9) | Moderate HI (n = 8) | Healthy match, moderate HI (n = 10) |
|---|---|---|---|---|
| Total mifamurtide | ||||
| AUCinf (nm h) | 104 (29) | 98.8 (15) | 103 (50) | 86.8 (17)* |
| Cmax (nm) | 94.2 (23) | 96.4 (18) | 92.4 (48) | 81.3 (24) |
| t1/2 [h; mean (SD)] | 2.02 (0.291) | 2.15 (0.308) | 3.21 (1.27) | 2.14 (0.322)* |
| CL (ml min−1) | 520 (29) | 546 (16) | 522 (38) | 621 (18)* |
| Vss (l) | 24.8 (27) | 22.3 (19) | 38.9 (55) | 28.4 (24)* |
| Free mifamurtide | ||||
| AUCinf (nm h) | 23.8 (38) | 16.2 (19) | 24.9 (71) | 17.0 (44) |
| Cmax (nm) | 8.65 (28) | 5.85 (26) | 6.21 (60) | 5.67 (32) |
| t1/2 [h; mean (SD)] | 1.99 (0.329) | 2.25 (0.504) | 3.15 (0.939) | 2.27 (0.460) |
| Tmax [h; median (range)] | 1.00 (1.0–1.3) | 1.00 (0.8–1.0) | 1.00 (1.0–1.1) | 1.00 (0.8–1.0) |
Abbreviations are as follows: AUCinf, area under the plasma concentration–time curve from time 0 to infinity; CL, clearance; Cmax, maximal concentration; CV, coefficient of variation; HI, hepatic impairment; Tmax, time to first occurrence of maximal concentration; t1/2, terminal half-life; and Vss, volume of distribution at steady state.
*
n = 9.