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. 2021 Sep 17;65(10):e01029-21. doi: 10.1128/AAC.01029-21

TABLE 1.

Demographics and baseline characteristics for single ascending dose safety population

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
a

CV%, coefficient of variation.