Table 2.
PK Parameters Following a Single 60‐mg Dose of Atogepant
| PK Parameter, Mean (SD) | Severe Hepatic Impairment (n = 8) | Moderate Hepatic Impairment (n = 8) | Mild Hepatic Impairment (n = 8) | Normal Hepatic Function (n = 8) |
|---|---|---|---|---|
| Cmax (ng/mL) | 543 (197) | 529 (227) | 666 (372) | 589 (248) |
| Tmax (h)a | 1.0 (0.5–3.0) | 1.5 (1.0–6.0) | 1.8 (1.0–4.0) | 1.8 (1.0–3.0) |
| AUC0‐t (ng·h/mL) | 3797 (1397) | 3270 (1693) | 3473 (1425) | 2758 (919) |
| AUC0‐∞ (ng·h/mL) | 3836 (1440) | 3314 (1684) | 3495 (1425) | 2780 (924.4) |
| t1/2 (h) | 7.5 (3.0) | 11.9 (7.6) | 8.7 (4.1) | 9.4 (3.2) |
| CL/F (L/h) | 17.3 (5.4) | 21.3 (8.1) | 19.4 (6.6) | 24.2 (9.4) |
| Free fraction in plasma | 4.7 (0.9) | 3.0 (0.6) | 2.7 (0.7) | 1.8 (0.5) |
AUC0‐∞, area under the plasma concentration‐time curve from time 0 to infinity; AUC0‐t, area under the plasma concentration‐time curve from time 0 to time t; CL/F, apparent total body clearance of drug from plasma after extravascular administration; Cmax, maximum plasma concentration; PK, pharmacokinetic; SD, standard deviation; Tmax, time to maximum plasma concentration; t1/2, apparent terminal elimination half‐life.
a
Median (range).