TABLE 1.
Part 1 study population
| Parameter | PBO (n = 14) | 1 mg PP (n = 6) | 3 mg PP (n = 6) | 10 mg PP (n = 6) | 30 mg PP (n = 6) | 30 mg EP (n = 6) | 30 mg EP FE (n = 8) | 60 mg EP (n = 6) | 120 mg EP (n = 6) | Total (N = 64) |
|---|---|---|---|---|---|---|---|---|---|---|
| Age (years) | ||||||||||
| Median | 35 | 30 | 32 | 34 | 30 | 35 | 27 | 29 | 46 | 32 |
| Min, max | 23, 44 | 20, 47 | 24, 41 | 30, 45 | 21, 40 | 19, 55 | 20, 43 | 26, 34 | 32, 53 | 19, 55 |
| Male sex a | 7 (50) | 3 (50) | 1 (17) | 2 (33) | 1 (17) | 4 (67) | 6 (75) | 6 (100) | 5 (83) | 35 (55) |
| Hispanic or Latino a | 3 (21) | 1 (17) | 1 (17) | 2 (33) | 0 | 0 | 1 (13) | 0 | 2 (33) | 10 (16) |
| Race | ||||||||||
| White a | 0 | 1 (17) | 0 | 1 (17) | 1 (17) | 1 (17) | 2 (25) | 0 | 1 (17) | 7 (11) |
| Black or AA a | 13 (93) | 5 (83) | 6 (100) | 5 (83) | 5 (83) | 5 (83) | 6 (75) | 6 (100) | 5 (83) | 56 (88) |
| Asian a | 1 (7) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (2) |
| Other | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| BMI (kg/m2) | ||||||||||
| Median | 28 | 24 | 29 | 25 | 27 | 26 | 27 | 26 | 27 | 27 |
| Min, max | 19, 31 | 22, 28 | 22, 31 | 21, 29 | 24, 30 | 22, 31 | 19, 31 | 22, 30 | 24, 31 | 18, 31 |
Abbreviations: AA, African American; BMI, body mass index; EP, extemporaneously prepared; FE, food effect; PBO, placebo; PP, pre‐prepared.
a
Data expressed as number (%).