Table 1.
Demographic data
| Subject group, dose regimen, and dose (mg) | Total no. of subjects | No. of male subjects | No. of female subjects | Mean body weight (kg) | Mean BMI (kg/m2) | Mean age (yr) |
|---|---|---|---|---|---|---|
| Part A, single dose | ||||||
| 25 | 3 | 2 | 1 | 76.4 | 23.8 | 41.7 |
| 50 | 6 | 6 | 0 | 72.7 | 23.5 | 39.3 |
| 100 | 6 | 5 | 1 | 76.4 | 24.2 | 38.3 |
| 200 | 6 | 5 | 1 | 74.1 | 24.4 | 36.7 |
| 400 | 6 | 5 | 1 | 76.3 | 25.1 | 37.8 |
| 800 | 6 | 5 | 1 | 73.3 | 23.7 | 37.0 |
| Placebo, single dose | 10 | 7 | 3 | 72.1 | 23.9 | 44.4 |
| Part B, 7 days q.d. | ||||||
| 150 | 6 | 5 | 1 | 70.0 | 23.5 | 44.0 |
| 300 | 6 | 5 | 1 | 78.4 | 24.4 | 46.8 |
| 600 | 6 | 6 | 0 | 79.1 | 24.3 | 43.7 |
| 800 | 6 | 6 | 0 | 81.2 | 24.8 | 44.8 |
| Placebo, multiple dose | 8 | 7 | 1 | 79.6 | 25.7 | 42.3 |
| Part C, 7 days q.d. | ||||||
| 600 | 20 | 20 | 20 | 75.7 | 24.3 | 41.6 |