All | Placebo | BMS-932481 | ||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Placebo | Treated | NHY | Elderly | CSF | 10 mg | 30 mg | 100 mg | 300 mg P | 300 mg P2 | 300 mg P3 | 600 mg | 900 mg | 1200 mg | 900 mg El | 900 mg C | |
Participants, n | 22 | 61 | 14 | 3 | 5 | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 |
Deaths | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
SAEs | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Discontinuation due to AEs | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
AEs | 7 (31.8) | 17 (27.9) | 24 (28.6) | 1 (33.3) | 2 (40.0) | 3 (50.0) | 2 (33.3) | 1 (16.7) | 0 | 0 | 1 (16.7) | 0 | 3 (50.0) | 0 | 0 | 7 (70.0) |
Drug-related AEs | 1 (4.5) | 2 (3.3) | 1 (7.1) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (16.7) | 0 | 0 | 1 (10.0) |
E1, Elderly; NHY, Normal healthy young; P1, P2, P3, cross-over phase 1, 2 or 3.