Table 2.
Adverse event, n subjects (%) | Part A | Part B (250 mg P218) | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
10 mg (n = 6) | 30 mg (n = 6) | 100 mg (n = 6) | 250 mg (n = 6) | 500 mg (n = 6) | 750 mg (n = 6) | 1000 mg (n = 6) | Placebo (n = 14) | Fasted (n = 8) | Fed (n = 8) | |
Any adverse events | 0 | 0 | 2 (33.3) | 1 (16.7) | 2 (33.3) | 3 (50.0) | 3 (50.0) | 3 (21.4) | 0 | 1 (12.5) |
Presyncope | 0 | 0 | 0 | 0 | 1 (16.7) | 0 | 0 | 0 | 0 | 0 |
Dizziness | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (12.5) |
Abdominal pain | 0 | 0 | 0 | 0 | 0 | 0 | 2 (33.3) | 0 | 0 | 0 |
Constipation | 0 | 0 | 1 (16.7) | 1 (16.7) | 0 | 0 | 0 | 0 | 0 | 0 |
Faeces soft | 0 | 0 | 0 | 0 | 0 | 0 | 1 (16.7) | 0 | 0 | 0 |
Nausea | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (12.5) |
Nasopharyngitis | 0 | 0 | 0 | 0 | 0 | 2 (33.3) | 0 | 1 (7.1) | 0 | 0 |
Sinusitis | 0 | 0 | 1 (16.7) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Back pain | 0 | 0 | 0 | 0 | 0 | 2 (33.3) | 0 | 0 | 0 | 0 |
Headache | 0 | 0 | 0 | 0 | 1 (16.7) | 0 | 1 (16.7) | 1 (7.1) | 0 | 1 (12.5) |
Paraesthesia | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (12.5) |
Oropharyngeal pain | 0 | 0 | 0 | 0 | 0 | 0 | 1 (16.7) | 1 (7.1) | 0 | 0 |
All events were mild, except one case of moderate back pain (Part A: 750 mg).