Table 1.
*Preferred term | Placebo | 0.03 g | 0.10 g | 0.25 g | 0.50 g | 1.0 g | 2.0 g* | 3.0 g | All SRT2104 |
---|---|---|---|---|---|---|---|---|---|
(n = 16) | (n = 4) | (n = 4) | (n = 12) | (n = 24) | (n = 5) | (n = 12) | (n = 4) | (n = 65) | |
Headache | 1 (6%) | 0 | 1 (25%) | 0 | 8 (33%) | 1 (20%) | 6 (50%) † | 2 (50%) | 18 (28%) |
Flatulence | 3 (19%) | 2 (50%) | 0 | 0 | 3 (13%) | 2 (40%) | 2 (17%) | 0 | 9 (14%) |
Infusion site pain | 0 | 0 | 0 | 5 (42%) | 0 | 0 | 0 | 0 | 5 (8%) |
Nausea | 1 (6%) | 0 | 1 (25%) | 0 | 2 (8%) | 0 | 1 (8%) | 1 (25%) | 5 (8%) |
Diarrhoea | 0 | 3 (75%) | 0 | 0 | 1 (4%) | 0 | 0 | 0 | 4 (6%) |
Nasopharyngitis | 0 | 0 | 0 | 0 | 2 (8%) | 0 | 1 (8%) | 1 (25%) | 4 (6%) |
MedDRA. Expressed as count (% of total).
The only AEs occurring in three or more subjects in the fed state were headaches.
Headache occurred in three subjects in the fasted state and three in the fed state.