TABLE 1.
Demographic and clinical characteristics of the participants at baseline a .
| Characteristic | Single dose | Multiple-dose | Total | ||
|---|---|---|---|---|---|
| 1.5 mg | 2.5 mg | 5 mg | 2.5 mg | ||
| N | 12 | 12 | 12 | 13 | 49 |
| Age, yr | 28.3 (20–40) | 26.7 (21–35) | 28.8 (21–39) | 29.8 (20–50) | 28.4 (20–50) |
| Sex, no. (%) | |||||
| Men | 7 (58.3) | 10 (83.3) | 9 (75.0) | 9 (69.2) | 35 (71.4) |
| Female | 5 (41.7) | 2 (16.7) | 3 (25.0) | 4 (30.8) | 14 (28.6) |
| Height, cm | 166.25 (154–176) | 168.46 (158.5–179) | 165.13 (146.5–177.5) | 166.04 (149–177) | 166.46 (146.5–179) |
| Weight, kg | 60.32 (50.5–74.3) | 62.74 (56.9–72.6) | 62.34 (46.4–71.4) | 63.15 (47.7–77.6) | 62.16 (46.4–77.6) |
| BMI, kg/m2 | 21.78 (20.5–25) | 22.17 (19.4–25.2) | 22.74 (20.7–25.7) | 22.78 (19.7–25.9) | 22.38 (19.4–25.9) |
a
Age, height, weight and BMI, data are presented as means (range). One participant in the multiple-dose part did not receive the study drug regimen according to the protocol and was excluded from the PK, and safety analyses.