TABLE 9.
Summary of changes in FXIa activity following treatment with BAY 2433334 in Part A
| Characteristic | Day | Treatment | Geometric mean | Geometric coefficient of variation (%) | P vs. placebo a |
|---|---|---|---|---|---|
| Maximal relative increase | 1 | BAY 2433334 100 mg (n = 9) | n.c. | n.c. | n.c. |
| BAY 2433334 50 mg (n = 9) | n.c. | n.c. | n.c. | ||
| BAY 2433334 25 mg (n = 9) | 0.133 | 35.24 | .0002 | ||
| Placebo (n = 9) | 0.896 | 9.38 | n.a. | ||
| 12 | BAY 2433334 100 mg (n = 8) | n.c. | n.c. | n.c. | |
| BAY 2433334 50 mg (n = 9) | n.c. | n.c. | n.c. | ||
| BAY 2433334 25 mg (n = 9) | 0.065 | 45.42 | .0002 | ||
| Placebo (n = 9) | 0.825 | 9.24 | n.a. | ||
| Ratio to baseline at 12 h | 1 | BAY 2433334 100 mg (n = 9) | n.c. | n.c. | n.c. |
| BAY 2433334 50 mg (n = 9) | 0.105 | 41.88 | .0002 | ||
| BAY 2433334 25 mg (n = 9) | 0.287 | 20.58 | .0002 | ||
| Placebo (n = 9) | 0.986 | 14.69 | n.a. | ||
| 12 | BAY 2433334 100 mg (n = 8) | n.c. | n.c. | n.c. | |
| BAY 2433334 50 mg (n = 9) | n.c. | n.c. | n.c. | ||
| BAY 2433334 25 mg (n = 9) | 0.157 | 26.04 | .0002 | ||
| Placebo (n = 9) | 0.906 | 8.47 | n.a. | ||
| Ratio to baseline at 24 h | 1 | BAY 2433334 100 mg (n = 9) | 0.076 | 121.32 | .0002 |
| BAY 2433334 50 mg (n = 9) | 0.234 | 35.35 | .0002 | ||
| BAY 2433334 25 mg (n = 9) | 0.495 | 17.21 | .0002 | ||
| Placebo (n = 9) | 1.030 | 12.44 | n.a. | ||
| 12 | BAY 2433334 100 mg (n = 8) | n.c. | n.c. | n.c. | |
| BAY 2433334 50 mg (n = 9) | 0.110 | 42.53 | .0002 | ||
| BAY 2433334 25 mg (n = 9) | 0.304 | 25.76 | .0002 | ||
| Placebo (n = 9) | 0.917 | 6.04 | n.a. |
FXIa, activated factor XI; n.a., not applicable; n.c., not calculated (statistics were only calculated if at least 2/3 of the individual data were measured, and were above the lower limit of quantification).
a
Wilcoxon test.