Table 3.
Atogepant PK Parameters Following a Single 60‐mg Dose of Atogepant in Participants With Severe, Moderate, or Mild Hepatic Impairment Compared With Participants With Normal Hepatic Function
| Hepatic Function Category | PK Parameter | Participants With Hepatic Impairment, GM | Participants With Normal Hepatic Function, GM | Impaired/Normal GMR (90%CI) |
|---|---|---|---|---|
| Severe impairment (n = 8) | Cmax (ng/mL) | 515 | 539 | 95.7 (63.9–143.4) |
| AUC0‐t (ng·h/mL) | 3602 | 2612 | 137.9 (99.5–191.1) | |
| AUC0‐∞ (ng·h/mL) | 3633 | 2633 | 138.0 (99.8–190.7) | |
| Moderate impairment (n = 8) | Cmax (ng/mL) | 475 | 539 | 88.2 (58.8–132.1) |
| AUC0‐t (ng·h/mL) | 2977 | 2612 | 114.0 (82.3–157.9) | |
| AUC0‐∞ (ng·h/mL) | 3029 | 2633 | 115.0 (83.2–159.0) | |
| Mild impairment (n = 8) | Cmax (ng/mL) | 587 | 539 | 109.0 (72.7–163.3) |
| AUC0‐t (ng·h/mL) | 3250 | 2612 | 124.4 (89.8–172.4) | |
| AUC0‐∞ (ng·h/mL) | 3274 | 2633 | 124.3 (89.9–171.8) |
AUC0‐∞, area under the concentration‐time curve from time 0 to infinity; AUC0‐t, area under the plasma concentration‐time curve from time 0 to time t; Cmax, maximum plasma concentration; GM, geometric mean; GMR, geometric mean ratio; PK, pharmacokinetic.