TABLE 2.
Safety profile of BAY 2433334 in healthy volunteers
| Part 1 (n = 70) | Part 2 (n = 16) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Placebo (n = 14) | BAY 2433334 Oral Solution, mg | BAY 2433334 IR Tablet, mg | BAY 2433334 5 × 5 mg IR Tablet | |||||||
| 5 (n = 8) | 12.5 (n = 8) | 25 (n = 8) | 25 (n = 8) | 50 (n = 8) | 100 (n = 8) | 150 (n = 8) | Fasted (n = 16) | Fed (n = 16) | ||
| TEAEs | 1 (7.1) | 2 (25) | 1 (12.5) | 2 (25) | 1 (12.5) | 1 (12.5) | 3 (37.5) | 5 (62.5) | 1 (6.3) | 6 (37.5) |
| Mild | 1 (7.1) | 2 (25) | 1 (12.5) | 2 (25) | 1 (12.5) | 1 (12.5) | 3 (37.5) | 5 (62.5) | 1 (6.3) | 6 (37.5) |
| Drug‐related TEAEs | 0 | 1 (12.5) | 1 (12.5) | 0 | 0 | 0 | 0 | 4 (50) | 1 (6.3) | 2 (12.5) |
| Serious AEs | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Serious TEAEs | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| AEs leading to discontinuation | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Data are presented as n (%).
Abbreviations: AE, adverse event; IR, immediate‐release; TEAE, treatment‐emergent adverse event.