Table 2.
Safety summary from the ALZ-801 (tablet) phase I single dose ascending study (i.e. Study 3 in Table 1): incidence of adverse events
| System organ class | Regimen A (n = 10) | Regimen B (n = 11) | Regimen C (n = 12) | Regimen D (n = 12) |
|---|---|---|---|---|
| Subjects reporting AEs | 4 | 4 | 0 | 3 |
| Gastrointestinal disorders | 4 | 4 | 0 | 3 |
| Flatulence | 0 | 0 | 0 | 0 |
| Nausea | 4 | 4 | 0 | 3 |
| Vomiting | 1 | 1 | 0 | 0 |
| Nervous system disorders | 0 | 0 | 0 | 0 |
| Headache | 0 | 0 | 0 | 0 |
| Somnolence | 0 | 0 | 0 | 0 |
| General disorders and administration site conditions | 0 | 0 | 0 | 0 |
| Chills | 0 | 0 | 0 | 0 |
| Vascular disorders | 0 | 0 | 0 | 0 |
| Flushing | 0 | 0 | 0 | 0 |
Regimen A: 171 mg ALZ-801 tablet (equivalent to 100 mg tramiprosate), administered in the fasted state
Regimen B: 205 mg ALZ-801 tablet (equivalent to 120 mg tramiprosate), administered in the fasted state
Regimen C: 205 mg ALZ-801 tablet (equivalent to 120 mg tramiprosate), administered in the fed state (30 min after starting a high-fat breakfast)
Regimen D: 342 mg ALZ-801 as 2 × 171 mg ALZ-801 tablets (equivalent to a total dose of 200 mg tramiprosate) administered in the fed state (30 min after starting a high-fat breakfast)
A total of 12 subjects were enrolled in the study. Ten subjects were enrolled and dosed in period 1 of the study, and were successfully dosed with Regimen A. An additional two subjects were enrolled for study periods 2–4. One subject was not dosed in study period 2 due to an unrelated AE, but returned to the study for regimens c and d
AEs adverse events