Table 1.
Demographics and disposition of subjects
| Part A (2‐h IV infusion) | PLA (N = 8) | 1.5 mg h −1 (N = 6) | 4 mg h −1 (N = 6) | 10 mg h −1 (N = 6) | 25 mg h −1 (N = 6) | Total (N = 32) |
|---|---|---|---|---|---|---|
| Age, years | ||||||
| Mean (SD) | 36.1 (8.46) | 30.7 (8.48) | 32.2 (4.02) | 27.3 (6.25) | 29.0 (2.83) | 31.2 (7.17) |
| Gender, n (%) | ||||||
| Male | 8 (100) | 6 (100) | 6 (100) | 6 (100) | 6 (100) | 32 (100) |
| Female | 0 | 0 | 0 | 0 | 0 | 0 |
| Weight, kg | ||||||
| Mean (SD) | 79.7 (8.55) | 77.2 (10.7) | 83.3 (13.3) | 72.6 (17.5) | 80.7 (19.5) | 78.8 (13.7) |
| Race, n (%) | ||||||
| White | 4 (50.0) | 1 (16.7) | 1 (16.7) | 3 (50.0) | 1 (16.7) | 10 (32.2) |
| Black/African American | 3 (37.5) | 3 (50.0) | 2 (33.3) | 3 (50.0) | 4 (66.7) | 15 (46.9) |
| Native Hawaiian or other Pacific Islander | 0 | 0 | 0 | 0 | 1 (16.7) | 1 (3.1) |
| Other | 1 (12.5) | 2 (33.3) | 3 (50.0) | 0 | 0 | 6 (18.8) |
| Part B (5‐day IV infusion) | PLA (N = 8) | 1 mg h−1 (N = 9) | 3 mg h−1 (N = 8) | 9 mg h−1 (N = 9) | 20 mg h−1 (N = 8) | Total (N = 42) |
|---|---|---|---|---|---|---|
| Age, years | ||||||
| Mean (SD) | 32.4 (4.00) | 35.0 (8.26) | 33.5 (7.13) | 31.9 (4.51) | 31.4 (8.42) | 32.9 (6.52) |
| Gender, n (%) | ||||||
| Male | 8 (100) | 9 (100) | 8 (100) | 9 (100) | 8 (100) | 42 (100) |
| Female | 0 | 0 | 0 | 0 | 0 | 0 |
| Weight, kg | ||||||
| Mean (SD) | 80.4 (11.4) | 81.9 (13.7) | 83.7 (14.4) | 71.8 (10.2) | 73.2 (13.2) | 78.2 (12.9) |
| Race, n (%) | ||||||
| White | 3 (37.5) | 2 (22.2) | 2 (25.0) | 3 (33.3) | 3 (37.5) | 13 (31.0) |
| Black/African American | 1 (12.5) | 2 (22.2) | 2 (25.0) | 0 | 0 | 5 (11.9) |
| American Indian or Alaska Native | 0 | 0 | 0 | 1 (11.1) | 0 | 1 (2.4) |
| Japanese | 4 (50.0) | 5 (55.5) | 4 (50.0) | 4 (44.4) | 4 (50.0) | 21 (50.0) |
| Other | 0 | 0 | 0 | 1 (11.1) | 1 (12.5) | 2 (4.8) |
IV, intravenous; PLA, placebo; SD, standard deviation