Table 1.
Participant demographics and baseline clinical characteristics
| Characteristic | Period 1 (N = 12) | Period 2 (N = 10)a |
|---|---|---|
| Age (years) | ||
| Mean (SD) | 34.4 (7.7) | 36.6 (6.1) |
| Median | 34.0 | 36.0 |
| Minimum, maximum | 20, 45 | 27, 45 |
| Sex, n (%) | ||
| Male | 12 (100.0) | 10 (100.0) |
| Race, n (%) | ||
| White | 5 (41.7) | 5 (50) |
| Black or African American | 5 (41.7) | 5 (50) |
| Asian | 1 (8.3) | 0 |
| Multiracial | 1 (8.3) | 0 |
| Ethnicity, n (%) | ||
| Hispanic or Latino | 5 (41.7) | 5 (50) |
| Not Hispanic or Latino | 7 (58.3) | 5 (50) |
| Height (cm) | ||
| Mean (SD) | 178.3 (6.1) | 178.6 (4.3) |
| Median | 179.4 | 179.4 |
| Minimum, maximum | 166.2, 188.1 | 171.8, 185.3 |
| Weight (kg) | ||
| Mean (SD) | 78.9 (11.1) | 81.2 (8.4) |
| Median | 80.4 | 80.4 |
| Minimum, maximum | 53.5, 99.8 | 71.3, 99.8 |
| Body mass index (kg/m2) | ||
| Mean (SD) | 24.7 (2.6) | 25.4 (2.0) |
| Median | 24.6 | 25.1 |
| Minimum, maximum | 19.4, 29.1 | 23.0, 29.1 |
SD standard deviation
aAll 12 enrolled participants (100%) were included in the safety and pharmacokinetic populations in period 1; as two subjects discontinued the study, the ten remaining subjects were included in period 2