Table 3.
Summary of adverse events (AEs) by treatment reported after single‐dose administration of ACT‐539313 (including adverse events judged to be unrelated to study drug)
| Treatment | ACT‐539313 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| 10 mg | 30 mg | 100 mg | 200 mg | 400 mg | Placebo | Total | |||
| (n = 6) | (n = 6) | (n = 6) | (n = 6) | (n = 6) | (n = 10) | (n = 40) | |||
| Condition | Fasted | Fed | Fasted | Fed | |||||
| Total subjects with AEs | 2 | 1 | 3 | 1 | 1 | 2 | ‐ | 1 | 11 |
| Total number of AEs | 2 | 1 | 4 | 1 | 1 | 3 | ‐ | 1 | 13 |
| Number of subjects reporting the AEs | |||||||||
| Somnolence | ‐ | ‐ | 2 | ‐ | 1 | 2 | ‐ | ‐ | 5 |
| Headache | 1 | 1 | ‐ | 1 | ‐ | ‐ | ‐ | ‐ | 3 |
| Hypervigilance | ‐ | ‐ | 1 | ‐ | ‐ | ‐ | ‐ | ‐ | 1 |
| Restlessness | ‐ | ‐ | ‐ | ‐ | ‐ | 1 | ‐ | ‐ | 1 |
| Toothache | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | 1 | 1 |
| Medical device site irritation | 1 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | 1 |
| Rhinitis | ‐ | ‐ | 1 | ‐ | ‐ | ‐ | ‐ | ‐ | 1 |