Table 1.
Summary of the AEs reported during SAD and MAD
| Treated participants | Participants with possibly drug-related AEs | Participants with definitively drug-related AEs | |
|---|---|---|---|
| SAD cohort (dose) | n | n | n |
| 1 (200 mg) | 4 | 0 | 0 |
| 2 (400 mg) | 4 | 3a | 0 |
| 3 (800 mg) | 3 | 0 | 2b |
| MAD cohort (dose) | n | n | n |
| 1 (200 mg) | 6 | 5c | 0 |
| 2 (300 mg) | 6 | 4d | 0 |
| 3 (400 mg) | 6 | 5e | 0 |
aOne participant with mild, self-resolving diarrhoea, one with headache and one with tiredness. Mild, self-resolved AEs.
bTwo with renal tubular damage, one of whom also had nausea and mild, self-resolving diarrhoea. Mild, self-resolved AEs.
cTwo with headache, two with loose stools and one with lightheadedness. Mild, self-resolved AEs.
dOne with headache, one with mild, self-resolving diarrhoea, one with abdominal pain and one with dysphagia. Mild, self-resolved AEs.
eOne with constipation, one with soft stools, two with headaches and one with increased thirst. Mild, self-resolved AEs.