Table I.
Participant Baseline Demographics
| Dose Cohort
|
|||||
|---|---|---|---|---|---|
| Placebo | 140 mg | 280 mg | 560 mg | 700 mg | |
| Male/female, n | 7:1 | 5:1 | 4:2 | 5:1 | 3:3 |
| White/black, n | 5:2 | 2:4 | 5:1 | 4:2 | 5:1 |
| Age, y | 51 (30, 57) | 55 (49, 64) | 52 (50, 59) | 51 (43, 54) | 55 (50, 60) |
| Weight, kg | 93 (61, 121) | 86 (61, 96) | 93 (71, 99) | 104 (86, 123) | 69 (49, 102) |
| BMI, kg/m2 | 30 (22, 49) | 27 (26, 30) | 28 (25, 42) | 33 (26, 41) | 25.2 (21.1, 36.4) |
| Total bilirubin, mg/dL | 0.6 (0.3, 0.9) | 0.7 (0.5, 1.0) | 0.8 (0.3, 1.0) | 0.6 (0.3, 1.4) | 0.6 (0.4, 0.8) |
| ALT, U/L | 77 (63, 163) | 73 (51, 124) | 152 (70, 288) | 113 (81, 214) | 95 (48, 164) |
| AST, U/L | 50 (39, 162) | 83 (40, 117) | 140 (61, 271) | 89 (46, 110) | 71 (47, 116) |
| Platelets, cells/mm3 | 225 (148, 402) | 175 (135, 229) | 196 (177, 308) | 192 (150, 225) | 192 (139, 276) |
| INR | 1 (0.9, 1.1) | 1.1 (1.0, 1.2) | 1.1 (1.0, 1.2) | 1.0 (1.0, 1.1) | 1.0 (0.9, 1.2) |
Data are presented as medians (minimum, maximum). ALT, alanine aminotransferase; AST, aspartate aminotransferase; BMI, body mass index; INR, international normalized ratio.