TABLE 7.
PK parameters of EC5026 in phase Ia fed‐fasted study.
| Parameter (unit) | EC5026 treatment group | |
|---|---|---|
| Fed (N = 14) | Fasted (N = 13) | |
| n | 13 a | 13 b |
| C max (ng/mL) | 55.6 (23.3) | 35.0 (32.1) |
| T max (h) | 8.25 (4.25, 24.17) | 4.25 (1.28, 36.00) |
| AUC0–t (ng•h/mL) | 4120 (20.5) | 3120 (23.2) |
| AUC0–inf (ng•h/mL) | 4260 (20.2) | 3260 (22.0) |
| AUC0–48 (ng•h/mL) | 1930 (20.1) | 1310 (25.2) |
| t 1/2 (h) | 59.5 (17.7) | 66.9 (17.2) |
| CL/F (L/h) | 1.91 (19.4) | 2.51 (23.3) |
| Vz/F (L) | 164 (43.7) | 244 (30.6) |
Note: Fed Treatment = 8 mg single oral dose of EC5026 in the fed state; Fasted Treatment = 8 mg single oral dose of EC5026 in the fasted state. Data are presented as geometric mean (geometric CV) except for t 1/2, CL/F, and Vz/F, which are arithmetic mean (arithmetic CV). For T max, the median (minimum, maximum) values are presented.
One subject received a pre‐dose meal 70 minutes prior to dosing (40 minutes outside of the window) in Period 1 (Fed Treatment); therefore, that subject was excluded from the calculation of summary statistics for the Fed Treatment.
One subject was dosed as planned in Period 1 (Fed Treatment) and was included in the calculation of summary statistics for the Fed Treatment but was withdrawn prior to Period 2 (Fasted Treatment).