|
Characteristic
|
Single ascending dose
|
Multiple ascending dose
|
|---|
|
500 mg (n = 8)
|
1000 mg (n = 8)
|
2000 mg (n = 8)
|
4000 mg (n = 8)
|
Overall (n = 32)
|
Placebo (n = 8)
|
250 mg BID (n = 8)
|
500 mg BID (n = 8)
|
1000 mg BID (n = 8)
|
Overall (n = 24)
|
Placebo (n = 6)
|
|---|
|
Age (years)
|
|
Mean ± SD
|
47.6 ± 14.94
|
42.0 ± 20.47
|
41.5 ± 15.58
|
40.6 ± 18.55
|
42.9 ± 16.89
|
28.3 ± 13.25
|
43.3 ± 10.43
|
47.9 ± 14.93
|
51.8 ± 13.51
|
47.6 ± 13.00
|
48.8 ± 20.91
|
|
Median
|
47.50
|
37.00
|
41.50
|
35.50
|
43.00
|
25.00
|
47.00
|
53.00
|
50.50
|
50.50
|
50.50
|
|
Min, max
|
23.0, 66.0
|
19.0, 67.0
|
21.0, 62.0
|
21.0, 69.0
|
19.0, 69.0
|
18.0, 58.0
|
27.0, 53.0
|
20.0, 69.0
|
29.0, 70.0
|
20.0, 70.0
|
25.0, 70.0
|
|
Sex, n (%)
|
|
Male
|
4 (50.0)
|
4 (50.0)
|
4 (50.0)
|
4 (50.0)
|
16 (50.0)
|
4 (50.0)
|
4 (50.0)
|
4 (50.0)
|
4 (50.0)
|
12 (50.0)
|
3 (50.0)
|
|
Race, n (%)
|
|
Asian
|
0
|
0
|
1 (12.5)
|
2 (25.0)
|
3 (9.4)
|
0
|
1 (12.5)
|
0
|
0
|
1 (4.2)
|
2 (33.3)
|
|
Black
|
2 (25.0)
|
2 (25.0)
|
1 (12.5)
|
0
|
5 (15.6)
|
2 (25.0)
|
1 (12.5)
|
2 (25.0)
|
2 (25.0)
|
5 (20.8)
|
1 (16.7)
|
|
White
|
6 (75.0)
|
5 (62.5)
|
6 (75.0)
|
6 (75.0)
|
23 (71.9)
|
6 (75.0)
|
6 (75.0)
|
6 (75.0)
|
6 (75.0)
|
18 (75.0)
|
3 (50.0)
|
|
Other
|
0
|
1 (12.5)
|
0
|
0
|
1 (3.1)
|
0
|
0
|
0
|
0
|
0
|
0
|
|
BMI (kg/m2)
|
|
Mean ± SD
|
26.2 ± 4.11
|
24.0 ± 4.11
|
23.0 ± 2.83
|
28.7 ± 4.73
|
25.5 ± 4.41
|
23.9 ± 4.02
|
27.6 ± 1.28
|
27.8 ± 4.37
|
26.8 ± 3.15
|
27.4 ± 3.08
|
25.8 ± 4.48
|
|
Median
|
24.29
|
25.31
|
22.37
|
27.51
|
25.50
|
22.17
|
27.70
|
27.80
|
25.90
|
27.40
|
25.55
|
|
Min, max
|
22.7, 32.4
|
17.9, 28.3
|
19.8, 27.6
|
22.0, 25.3
|
17.9, 35.3
|
20.2, 32.2
|
25.5, 29.7
|
21.6, 35.2
|
23.6, 32.7
|
21.6, 35.2
|
19.8, 31.7
|
-
BID Twice daily, BMI Body mass index, SD Standard deviation
