TABLE 2.
Most common adverse events (reported in ≥10% of participants in any treatment group)
| NT-814 once-daily dose | |||||
| Placebo N = 18 n (%) | 50 mg N = 15 n (%) | 100 mg N = 15 n (%) | 150 mg N = 15 n (%) | 300 mg N = 13 n (%) | |
| Any adverse event | 13 (72.2) | 7 (46.7) | 11 (73.3) | 10 (66.7) | 11 (84.6) |
| Somnolence | 3 (16.7) | 5 (33.3) | 2 (13.3) | 5 (33.3) | 9 (69.2) |
| Contact dermatitisa | 5 (27.8) | 2 (13.3) | 6 (40.0) | 5 (33.3) | 2 (15.4) |
| Headache | 3 (16.7) | 0 | 5 (33.3) | 1 (6.7) | 6 (46.2) |
| Diarrhea | 0 | 1 (6.7) | 0 | 1 (6.7) | 3 (23.1) |
| Pelvic pain | 2 (11.1) | 3 (20.0) | 0 | 0 | 0 |
| Viral upper respiratory tract infection | 1 (5.6) | 0 | 0 | 0 | 3 (23.1) |
| Dyspepsia | 2 (11.1) | 0 | 0 | 1 (6.7) | 0 |
| Alanine aminotransferase increased | 0 | 0 | 2 (13.3)b | 0 | 0 |
aFrom ECG electrodes.
bAlanine aminotransferase (ALT) increased to 1.3 × upper limit of normal (ULN) on day 8, decreasing to 1.1×ULN on day 14 in one participant; and to 2.6 × ULN on day 8, decreasing to 1.4×ULN on day 14 in the other participant. Four other participants (two receiving placebo and two receiving 300 mg NT-814) had similar changes in ALT that were not reported as adverse events.