Table 5.
Fezolinetant plasma concentrations, safety population
| Fezolinetant 60 mg (n = 23) | Fezolinetant 180 mg (n = 23) | |||||||
|---|---|---|---|---|---|---|---|---|
| No. | Mean (SE), ng/mL | Median, ng/mL | Range, ng/mL | No. | Mean (SE), ng/mL | Median, ng/mL | Range, ng/mL | |
| Predose samplesa | ||||||||
| Wk 1 (baseline) | 23 | 0 (0) | 0 | — | 22 | 0 (0) | 0 | — |
| Wk 9 (trough) | 20 | 57.51 (28.04) | 19.2 | 0-576.0 | 17 | 362.06 (121.84) | 153.0 | 0-1815.0 |
| Postdose (peak) samplesb | ||||||||
| Wk 3 | 22 | 423.35 (57.53) | 395.5 | 13.5-1023.0 | 18 | 1371.20 (149.55) | 1431.5 | 9.7-2266.0 |
| Wk 6 | 21 | 468.91 (43.94) | 440.0 | 0-847.0 | 17 | 1433.59 (110.24) | 1415.0 | 753.0-2401.0 |
| Wk 12 | 21 | 417.24 (59.07) | 424.0 | 0-927.0 | 17 | 1361.88 (153.53) | 1299.0 | 0-2428.0 |
a Blood samples for fezolinetant concentrations were taken before intake of study drug.
b Blood samples for fezolinetant concentrations were taken 2 to 8 hours after intake of study drug.