Table 1.
Demographics and baseline characteristics
| Characteristic | Single ascending dose | Multiple ascending dose | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 500 mg (n = 8) | 1000 mg (n = 8) | 2000 mg (n = 8) | 4000 mg (n = 8) | Overall (n = 32) | Placebo (n = 8) | 250 mg BID (n = 8) | 500 mg BID (n = 8) | 1000 mg BID (n = 8) | Overall (n = 24) | Placebo (n = 6) | |
| Age (years) | |||||||||||
| Mean ± SD | 47.6 ± 14.94 | 42.0 ± 20.47 | 41.5 ± 15.58 | 40.6 ± 18.55 | 42.9 ± 16.89 | 28.3 ± 13.25 | 43.3 ± 10.43 | 47.9 ± 14.93 | 51.8 ± 13.51 | 47.6 ± 13.00 | 48.8 ± 20.91 |
| Median | 47.50 | 37.00 | 41.50 | 35.50 | 43.00 | 25.00 | 47.00 | 53.00 | 50.50 | 50.50 | 50.50 |
| Min, max | 23.0, 66.0 | 19.0, 67.0 | 21.0, 62.0 | 21.0, 69.0 | 19.0, 69.0 | 18.0, 58.0 | 27.0, 53.0 | 20.0, 69.0 | 29.0, 70.0 | 20.0, 70.0 | 25.0, 70.0 |
| Sex, n (%) | |||||||||||
| Male | 4 (50.0) | 4 (50.0) | 4 (50.0) | 4 (50.0) | 16 (50.0) | 4 (50.0) | 4 (50.0) | 4 (50.0) | 4 (50.0) | 12 (50.0) | 3 (50.0) |
| Race, n (%) | |||||||||||
| Asian | 0 | 0 | 1 (12.5) | 2 (25.0) | 3 (9.4) | 0 | 1 (12.5) | 0 | 0 | 1 (4.2) | 2 (33.3) |
| Black | 2 (25.0) | 2 (25.0) | 1 (12.5) | 0 | 5 (15.6) | 2 (25.0) | 1 (12.5) | 2 (25.0) | 2 (25.0) | 5 (20.8) | 1 (16.7) |
| White | 6 (75.0) | 5 (62.5) | 6 (75.0) | 6 (75.0) | 23 (71.9) | 6 (75.0) | 6 (75.0) | 6 (75.0) | 6 (75.0) | 18 (75.0) | 3 (50.0) |
| Other | 0 | 1 (12.5) | 0 | 0 | 1 (3.1) | 0 | 0 | 0 | 0 | 0 | 0 |
| BMI (kg/m2) | |||||||||||
| Mean ± SD | 26.2 ± 4.11 | 24.0 ± 4.11 | 23.0 ± 2.83 | 28.7 ± 4.73 | 25.5 ± 4.41 | 23.9 ± 4.02 | 27.6 ± 1.28 | 27.8 ± 4.37 | 26.8 ± 3.15 | 27.4 ± 3.08 | 25.8 ± 4.48 |
| Median | 24.29 | 25.31 | 22.37 | 27.51 | 25.50 | 22.17 | 27.70 | 27.80 | 25.90 | 27.40 | 25.55 |
| Min, max | 22.7, 32.4 | 17.9, 28.3 | 19.8, 27.6 | 22.0, 25.3 | 17.9, 35.3 | 20.2, 32.2 | 25.5, 29.7 | 21.6, 35.2 | 23.6, 32.7 | 21.6, 35.2 | 19.8, 31.7 |
BID Twice daily, BMI Body mass index, SD Standard deviation