TABLE 1.
Part A | Part B | Part C | |||||
---|---|---|---|---|---|---|---|
Overall n = 56 |
Placebo n = 14 |
Enpatorana n = 42 |
Overall n = 40 |
Placebo n = 10 |
Enpatorana n = 30 |
Enpatoranb n = 8 |
|
Sex, n (%) | |||||||
Male | 55 (98.2) | 14 (100.0) | 41 (97.6) | 39 (97.5) | 10 (100.0) | 29 (96.7) | 7 (87.5) |
Female | 1 (1.8) | 0 (0.0) | 1 (2.4) | 1 (2.5) | 0 (0.0) | 1 (3.3) | 1 (12.5) |
Age, y | |||||||
Meanc ± SD | 31 ± 6.8 | 30 ± 6.5 | 32 ± 6.9 | 32 ± 8.0 | 30 ± 8.4 | 33 ± 7.9 | 34 ± 9.3 |
Minc, max | 18, 45 | 18, 43 | 20, 45 | 19, 45 | 19, 42 | 21, 45 | 18, 45 |
BMId, kg/m2 | |||||||
Meanc ± SD | 24.5 ± 2.55 | 24.4 ± 3.16 | 24.5 ± 2.35 | 24.7 ± 2.93 | 23.5 ± 3.48 | 25.1 ± 2.68 | 24.0 ± 2.74 |
Min, max | 18.9, 29.8 | 18.9, 29.8 | 19.9, 29.1 | 19.0, 29.3 | 19.0, 28.2 | 20.1, 29.3 | 18.9, 26.4 |
Abbreviations: BMI, body mass index; max, maximum; min, minimum; SD, standard deviation.
All doses.
Participants crossed over from Part A (Cohort 4, 25 mg) to Part C and all received a single 25 mg dose of enpatoran.
Arithmetic mean.
At screening.