Table 4.
Vasodilatory Adverse Events by Cohort
| Cohort | Dose | n | Tachycardia/palpitations (%) | Dizziness, light‐headedness (including postural/orthostatic dizziness, syncope, presyncope) (%) |
|---|---|---|---|---|
| SAD | 3.5 μg | 8 | 0 (0.0) | 0 (0.0) |
| 12 μg | 8 | 0 (0.0) | 0 (0.0) | |
| 32 μg | 8 | 0 (0.0) | 1 (12.5) | |
| 48 μg | 8 | 0 (0.0) | 0 (0.0) | |
| 72 μg | 8 | 0 (0.0) | 0 (0.0) | |
| 100 μg | 8 | 0 (0.0) | 2 (25.0) | |
| 124 μg | 8 | 0 (0.0) | 1 (12.5) | |
| Total | 56 | 0 (0.0) | 4 (7.1) | |
| Placebo | 13 | 0 (0.0) | 1 (7.7) | |
| MAD | 3.5 μg | 8 | 1 (12.5) | 1 (12.5) |
| 7 μg | 8 | 0 (0.0) | 1 (12.5) | |
| 12 μg | 10 | 0 (0.0) | 1 (12.5) | |
| 16 μg | 8 | 0 (0.0) | 0 (0.0) | |
| 20 μg | 8 | 1 (12.5) | 0 (0.0) | |
| 24 μg | 8 | 3 (37.5) | 2 (25.0) | |
| Total | 50 | 5 (10.0) | 5 (10.0) | |
| Placebo | 13 | 1 (7.7) | 2 (15.4) |
A subject experiencing orthostatic dizziness and palpitations is counted twice in this table; all events were adjudicated as at least possibly related to study drug.
SAD = single ascending dose; MAD = multiple ascending dose.