Table 1. Participant disposition, demographic, and baseline characteristics.
| Characteristics | Study 1 (n = 14) | Study 2 (n = 14) | Study 3 (n = 18) |
|---|---|---|---|
| Age (years), mean (SD) | 30.3 (8.44) | 29.1 (9.71) | 42.1 (9.57) |
| Sex, n (%) | |||
| Men | 14 (100) | 13 (93) | 15 (83) |
| Women | 0 (0) | 1 (7) | 3 (17) |
| Race, n (%) | |||
| Black or African-American | 3 (21) | 9 (64) | – |
| White | 11 (79) | 5 (36) | 18 (100) |
| Ethnicity, n (%) | |||
| Hispanic or Latino | 2 (14) | 2 (14) | – |
| Not Hispanic or Latino | 12 (86) | 12 (86) | 18 (100) |
| Weight (kg), mean (SD) | 75.0 (14.06) | 79.6 (11.19) | 80.5 (9.29) |
| Height (cm), mean (SD) | 176.8 (4.76) | 176.9 (7.49) | 177.1 (8.62) |
| BMI (kg/m2), mean (SD) | 23.9 (3.71) | 25.4 (2.73) | 25.7 (2.38) |
| Participants who completed the study | 14 | 11 | 18 |
| Withdrawn | |||
| Lost to follow-upa | – | 1 | – |
| Protocol violation | – | 1 | – |
| Physician decision | – | 1 | – |
BMI = body mass index; SD = standard deviation.aThis participant was considered to have completed the study per protocol as he had completed all required assessments of the open-label phase and was included in both the pharmacokinetic and statistical analyses. Note: Percentages calculated with the number of participants in each group as denominator.