Table 2.
Summary of Pomalidomide Plasma Pharmacokinetic Parameters (Study B)
| PK Parameters of Pomalidomide | Pomalidomide 4 mg Administered Alone, n = 15 | Pomalidomide 4 mg Administered With Fluvoxamine, n = 14 |
|---|---|---|
| AUC0‐inf (ng·h/mL) | 526.5 (33.2) | 1179.4 (23.4) |
| Cmax (ng/mL) | 49.2 (26.2) | 59.5 (21.9) |
| tmax (h)a | 3.0 (2.5, 6.0) | 4.5 (3.0, 6.0) |
| t1/2 (h) | 6.0 (28.9) | 13.1 (15.8) |
| CL/F (L/h) | 7.6 (33.2) | 3.4 (23.4) |
| Vz/F (L) | 65.4 (16.9) | 64.0 (16.8) |
Geometric mean (geometric CV%) data from descriptive statistics are presented.
AUC0‐inf, area under the plasma concentration‐time curve from time 0 to infinity; CL/F, apparent total plasma clearance; Cmax, maximum plasma drug concentration; n, number of subjects; t1/2, terminal half‐life; tmax, time to Cmax; Vz/F, apparent volume of distribution during the terminal phase when dosed orally.
a
Median (minimum, maximum).