TABLE 1.
Summary of demographic data
| Demographic | Part 1 |
Part 2a |
|||
|---|---|---|---|---|---|
| 16 mg (n = 6) | 32 mg (n = 6) | 80 mg (n = 6) | 32 mg (n = 6) | 80 mg (n = 6) | |
| Mean age in years (SD) | 28.2 (10.5) | 24.7 (3.7) | 22.2 (2.8) | 28.5 (7.8) | 30.8 (7.9) |
| Sex | |||||
| No. male (%) | 6 (100.0) | 6 (100.0) | 6 (100.0) | 4 (66.7) | 3 (50.0) |
| No. female (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (33.3) | 3 (50.0) |
| Race | |||||
| No. white (%) | 6 (100.0) | 5 (83.3) | 6 (100.0) | 6 (100.0) | 6 (100.0) |
| No. other (%) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Mean weight (kg) (SD) | 80.80 (9.45) | 76.23 (8.62) | 76.80 (4.04) | 60.50 (4.64) | 63.86 (4.96) |
| Mean height (cm) (SD) | 183.8 (5.3) | 181.7 (7.0) | 178.8 (4.6) | 168.7 (6.3) | 168.6 (4.2) |
| Mean body mass index (kg/m²) (SD) | 23.87 (2.14) | 23.13 (2.54) | 24.10 (2.26) | 21.32 (1.72) | 22.50 (1.85) |
a
One subject withdrew after the 32-mg dose and was replaced for the 80-mg dose by an alternative subject.