TABLE 2.
Incidence of treatment-emergent adverse events in SAD and MAD groups
| Preferred term | No. (%) of subjects |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Placebo, overall (n = 14) | Cohort 1, 100 mg (n = 6) | Cohort 2, 250 mg (n = 6) | Cohort 3, 500 mg (n = 6) | Cohort 4, 1,000 mg, fasted (n = 6) | Cohort 4, 1,000 mg, fed (n = 6) | Cohort 5, 1,500 mg (n = 6) | Cohort 6, 2,000 mg (n = 6) | Elderly, 500 mg (n = 6) | Overall, SPR720 (n = 42) | |
| SAD | ||||||||||
| Any TEAE | 3 (21.4) | 1 (16.7) | 2 (33.3) | 1 (16.7) | 1 (16.7) | 0 | 4 (66.7) | 6 (100) | 3 (50.0) | 18 (42.9) |
| Nausea | 0 | 0 | 0 | 0 | 0 | 0 | 4 (66.7) | 5 (83.3) | 0 | 9 (21.4) |
| Headache | 1 (7.1) | 0 | 0 | 0 | 1 (16.7) | 0 | 3 (50.0) | 3 (50.0) | 0 | 7 (16.7) |
| Vomiting | 0 | 0 | 0 | 0 | 0 | 0 | 3 (50.0) | 5 (83.3) | 0 | 8 (19.0) |
| Diarrhea | 0 | 0 | 0 | 1 (16.7) | 0 | 0 | 0 | 2 (33.3) | 0 | 3 (7.1) |
| Abdominal discomfort | 0 | 0 | 1 (16.7) | 0 | 0 | 0 | 0 | 0 | 0 | 1 (2.4) |
| Amylase increased | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (16.7) | 1 (2.4) |
| Dyspepsia | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (16.7) | 1 (2.4) |
| Neuralgia | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (16.7) | 1 (2.4) |
| Rhinorrhea | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (16.7) | 1 (2.4) |
| Skin abrasion | 0 | 1 (16.7) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (2.4) |
| Toothache | 0 | 0 | 1 (16.7) | 0 | 0 | 0 | 0 | 0 | 0 | 1 (2.4) |