Table 1.
Demographics and baseline characteristics (safety analysis set)
| Characteristics | Mild RI (n = 8) | Moderate RI (n = 8) | Severe RI (n = 8) | Normal RF (n = 8) |
|---|---|---|---|---|
| Sex [n (%)] | ||||
| Male | 5 (62.5) | 5 (62.5) | 3 (37.5) | 3 (37.5) |
| Female | 3 (37.5) | 3 (37.5) | 5 (62.5) | 5 (62.5) |
| Race [n (%)] | ||||
| White | 8 (100) | 8 (100) | 8 (100) | 8 (100) |
| Age (years) [mean (SD)] | 61.9 (10.9) | 58.8 (12.4) | 64.6 (10.6) | 60.4 (11.5) |
| BMI (kg/m2) [mean (SD)] | 27.6 (3.3) | 28.5 (2.9) | 29.9 (3.5) | 29.6 (3.6) |
| CLcr (mL/min) [mean (SD)] | 66.9 (8.3) | 40.0 (6.1) | 21.7 (6.0) | 111.7 (31.8) |
BMI body mass index, CLcr creatinine clearance, RF renal function, RI renal impairment, SD standard deviation