TABLE 2.
Demographics and baseline characteristics for the multiple ascending dose safety population
| Variable or category | Statisticb | No. (%) of patients |
|||||
|---|---|---|---|---|---|---|---|
| On placebo (n = 8) | On V-7404 ata: |
All participants (N = 41) | |||||
| 500 mg QD, fasted (n = 8) | 1,000 mg QD, fasted (n = 8) | 2,000 mg QD, fasted (n = 9) | 2,000 mg BID, fasted (n = 8) | ||||
| Gender | |||||||
| Male | n (%) | 3 (37.5) | 4 (50.0) | 4 (50.0) | 4 (44.4) | 4 (50.0) | 19 (46.3) |
| Female | n (%) | 5 (62.5) | 4 (50.0) | 4 (50.0) | 5 (55.6) | 4 (50.0) | 22 (53.7) |
| Race | |||||||
| American Indian or Alaska Native | n (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Asian | n (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (11.1) | 0 (0.0) | 1 (2.4) |
| Black or African American | n (%) | 6 (75.0) | 8 (100.0) | 5 (62.5) | 3 (33.3) | 2 (25.0) | 24 (58.5) |
| Native Hawaiian or other Pacific Islanders | n (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| White | n (%) | 2 (25.0) | 0 (0.0) | 3 (37.5) | 5 (55.6) | 6 (75.0) | 16 (39.0) |
| Multiple | n (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Other | n (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Ethnicity | |||||||
| Hispanic or Latino | n (%) | 1 (12.5) | 0 (0.0) | 2 (25.0) | 1 (11.1) | 1 (12.5) | 5 (12.2) |
| Not Hispanic or Latino | n (%) | 7 (87.5) | 8 (100.0) | 6 (75.0) | 8 (88.9) | 7 (87.5) | 36 (87.8) |
| Age (yrs) | n | 8 | 8 | 8 | 9 | 8 | 41 |
| Mean | 32.9 | 31.4 | 33.0 | 35.2 | 32.0 | 33.0 | |
| SD | 7.2 | 5.9 | 7.8 | 4.6 | 4.1 | 5.9 | |
| CV% | 22.0 | 18.7 | 23.5 | 13.0 | 12.9 | 17.9 | |
| Minimum | 25 | 19 | 20 | 27 | 27 | 19 | |
| Median | 33 | 32 | 33 | 37 | 33 | 33 | |
| Maximum | 44 | 38 | 43 | 41 | 40 | 44 | |
| Ht (cm) | n | 8 | 8 | 8 | 9 | 8 | 41 |
| Mean | 167.50 | 170.69 | 172.44 | 166.70 | 171.13 | 169.62 | |
| SD | 10.01 | 8.18 | 12.84 | 8.23 | 10.21 | 9.75 | |
| CV% | 6.0 | 4.8 | 7.4 | 4.9 | 6.0 | 5.7 | |
| Minimum | 155.0 | 156.0 | 158.0 | 148.0 | 152.0 | 148.0 | |
| Median | 166.0 | 173.8 | 168.3 | 167.0 | 173.8 | 168.5 | |
| Maximum | 186.0 | 178.0 | 194.0 | 178.0 | 183.0 | 194.0 | |
| Wt (kg) | n | 8 | 8 | 8 | 9 | 8 | 41 |
| Mean | 77.66 | 70.94 | 81.20 | 70.23 | 77.81 | 75.44 | |
| SD | 11.38 | 14.68 | 9.91 | 8.56 | 13.28 | 11.92 | |
| CV% | 14.7 | 20.7 | 12.2 | 12.2 | 17.1 | 15.8 | |
| Minimum | 60.8 | 56.0 | 71.7 | 57.7 | 49.2 | 49.2 | |
| Median | 76.4 | 68.4 | 78.0 | 68.4 | 82.5 | 75.3 | |
| Maximum | 98.1 | 94.7 | 100.9 | 86.5 | 93.8 | 100.9 | |
| Body mass index (kg/m2) | n | 8 | 8 | 8 | 9 | 8 | 41 |
| Mean | 27.40 | 24.61 | 27.53 | 25.44 | 26.46 | 26.27 | |
| SD | 2.09 | 5.01 | 2.40 | 3.45 | 3.12 | 3.40 | |
| CV% | 7.6 | 20.4 | 8.7 | 13.5 | 11.8 | 12.9 | |
| Minimum | 24.5 | 19.0 | 23.2 | 21.4 | 21.6 | 19.0 | |
| Median | 27.4 | 23.7 | 27.9 | 24.7 | 26.8 | 27.2 | |
| Maximum | 30.7 | 31.3 | 31.0 | 30.7 | 30.4 | 31.3 | |
a
BID, twice daily; QD, once daily.
b
CV%, coefficient of variation.