TABLE 1.
Variable or category | Statistica | No. (%) of patients |
|||||||
---|---|---|---|---|---|---|---|---|---|
On placebo (n = 12) | On V-7404 at: |
All participants (n = 36) | |||||||
200 mg (fasted, n = 4) | 500 mg (fasted, n = 4) | 500 mg (fed, n = 4) | 1,000 mg (fasted, n = 4) | 1,500 mg (fasted, n = 4) | 2,000 mg (fasted, n = 4) | ||||
Gender | |||||||||
Male | n (%) | 6 (50.0) | 1 (25.0) | 1 (25.0) | 2 (50.0) | 2 (50.0) | 0 (0.0) | 2 (50.0) | 14 (38.9) |
Female | n (%) | 6 (50.0) | 3 (75.0) | 3 (75.0) | 2 (50.0) | 2 (50.0) | 4 (100.0) | 2 (50.0) | 22 (61.1) |
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) | 0 (0.0) | 0 (0.0) |
Asian | n (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Black or African American | n (%) | 5 (41.7) | 1 (25.0) | 3 (75.0) | 0 (0.0) | 1 (25.0) | 3 (75.0) | 2 (50.0) | 15 (41.7) |
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) | 0 (0.0) | 0 (0.0) |
White | n (%) | 7 (58.3) | 2 (50.0) | 1 (25.0) | 4 (100.0) | 3 (75.0) | 1 (25.0) | 2 (50.0) | 20 (55.6) |
Multiple | n (%) | 0 (0.0) | 1 (25.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (2.8) |
Other | n (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Ethnicity | |||||||||
Hispanic or Latino | n (%) | 1 (8.3) | 1 (25.0) | 0 (0.0) | 1 (25.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 3 (8.3) |
Not Hispanic or Latino | n (%) | 11 (91.7) | 3 (75.0) | 4 (100.0) | 3 (75.0) | 4 (100.0) | 4 (100.0) | 4 (100.0) | 33 (91.7) |
Age (yrs) | n | 12 | 4 | 4 | 4 | 4 | 4 | 4 | 36 |
Mean | 31.3 | 35.3 | 31.3 | 23.3 | 30.0 | 26.8 | 32.0 | 30.3 | |
SD | 7.3 | 5.6 | 3.4 | 4.3 | 5.5 | 3.8 | 10.1 | 6.7 | |
CV% | 23.4 | 15.8 | 10.9 | 18.7 | 18.3 | 14.1 | 31.7 | 22.2 | |
Minimum | 21 | 30 | 27 | 19 | 23 | 23 | 23 | 19 | |
Median | 31 | 34 | 32 | 23 | 31 | 26 | 30 | 30 | |
Maximum | 45 | 43 | 34 | 29 | 36 | 32 | 45 | 45 | |
Ht (cm) | n | 12 | 4 | 4 | 4 | 4 | 4 | 4 | 36 |
Mean | 168.71 | 167.00 | 170.63 | 171.63 | 164.25 | 162.43 | 167.75 | 167.76 | |
SD | 7.89 | 6.23 | 2.36 | 13.59 | 4.99 | 4.19 | 13.23 | 8.09 | |
CV% | 4.7 | 3.7 | 1.4 | 7.9 | 3.0 | 2.6 | 7.9 | 4.8 | |
Minimum | 154.0 | 160.5 | 168.5 | 156.5 | 159.0 | 158.0 | 149.0 | 149.0 | |
Median | 167.5 | 167.0 | 170.0 | 172.5 | 164.5 | 162.1 | 172.0 | 168.0 | |
Maximum | 180.0 | 173.5 | 174.0 | 185.0 | 169.0 | 167.5 | 178.0 | 185.0 | |
Wt (kg) | n | 12 | 4 | 4 | 4 | 4 | 4 | 4 | 36 |
Mean | 73.70 | 82.93 | 67.55 | 65.93 | 71.80 | 67.15 | 76.45 | 72.54 | |
SD | 13.97 | 13.95 | 10.45 | 9.30 | 13.36 | 14.71 | 15.88 | 13.27 | |
CV% | 19.0 | 16.8 | 15.5 | 14.1 | 18.6 | 21.9 | 20.8 | 18.3 | |
Minimum | 56.8 | 66.0 | 54.3 | 53.6 | 55.9 | 52.5 | 58.4 | 52.5 | |
Median | 71.1 | 84.7 | 69.8 | 67.0 | 72.7 | 66.1 | 78.2 | 71.1 | |
Maximum | 97.2 | 96.3 | 76.4 | 76.2 | 85.9 | 83.9 | 91.1 | 97.2 | |
Body mass index (kg/m2) | n | 12 | 4 | 4 | 4 | 4 | 4 | 4 | 36 |
Mean | 25.88 | 29.55 | 24.18 | 22.58 | 26.60 | 25.00 | 26.70 | 25.80 | |
SD | 3.86 | 2.91 | 4.54 | 2.41 | 4.52 | 4.65 | 2.54 | 3.89 | |
CV% | 14.9 | 9.9 | 18.8 | 10.7 | 17.0 | 18.6 | 9.5 | 15.1 | |
Minimum | 20.0 | 25.7 | 19.3 | 19.8 | 22.3 | 20.1 | 23.7 | 19.3 | |
Median | 25.4 | 30.3 | 23.8 | 22.5 | 26.8 | 24.6 | 26.8 | 25.7 | |
Maximum | 31.7 | 32.0 | 29.9 | 25.6 | 30.5 | 30.7 | 29.5 | 32.0 |
CV%, coefficient of variation.