Table 1.
Baseline Demographics and Subject Characteristics in the Renal Impairment Study and the Hepatic Impairment Study
| Renal Impairment Study | |||||
|---|---|---|---|---|---|
| Parameter | Mild (n = 9) | Moderate (n = 9) | Severe (n = 6) | ESRD (n = 8) | Normal Function (n = 9) |
| Age, y | 61.2 (10.6) | 66.6 (5.9) | 61.2 (3.3) | 51.8 (10.7) | 62.8 (4.1) |
| Weight, kg | 80.9 (19.0) | 80.0 (14.4) | 94.4 (6.9) | 75.6 (16.0) | 87.3 (13.2) |
| BMI, kg/m2 | 27.8 (5.0) | 28.6 (4.0) | 34.1 (2.9) | 25.9 (4.3) | 29.1 (3.3) |
| Sex, n (%) | |||||
| Male | 7 (77.8) | 4 (44.4) | 4 (66.7) | 4 (50.0) | 5 (55.6) |
| Female | 2 (22.2) | 5 (55.6) | 2 (33.3) | 4 (50.0) | 4 (44.4) |
| Race, n (%) | |||||
| White | 8 (88.9) | 7 (77.8) | 5 (83.3) | 2 (25.0) | 6 (66.7) |
| Black | 1 (11.1) | 1 (11.1) | 1 (16.7) | 5 (62.5) | 2 (22.2) |
| American Indian or Alaska Native | 0 (0.0) | 1 (11.1) | 0 (0.0) | 1 (12.5) | 1 (11.1) |
| eGFR, mL/(min·1.73 m2) | 72.6 (7.3) | 50.3 (5.6) | 20.0 (3.4) | 9.9 (5.0) | 97.9 (26.0) |
| CLcr, mL/min | 82.0 (17.0) | 58.8 (11.4) | 31.8 (4.1) | 14.3 (8.5) | 114.4 (16.9) |
| Hepatic Impairment Study | |||
|---|---|---|---|
| Parameter | Mild (n = 8) | Moderate (n = 8) | Normal Function (n = 8) |
| Age, y | 57.5 (6.4) | 57.0 (5.8) | 51.4 (5.9) |
| Weight, kg | 90.3 (16.6) | 79.1 (14.0) | 82.9 (16.7) |
| BMI, kg/m2 | 30.6 (4.5) | 28.0 (4.6) | 29.0 (4.0) |
| Sex, n (%) | |||
| Male | 5 (62.5) | 5 (62.5) | 5 (62.5) |
| Female | 3 (37.5) | 3 (37.5) | 3 (37.5) |
| Race, n (%) | |||
| White | 7 (87.5) | 6 (75.0) | 7 (87.5) |
| Black | 1 (12.5) | 1 (12.5) | 1 (12.5) |
| American Indian or Alaska Native | 0 (0.0) | 1 (12.5) | 0 (0.0) |
| Child‐Pugh score, n (%) | |||
| 5 or 6 | 8 (100.0) | 0 | 0 |
| 7 to 9 | 0 | 8 (100.0) | 0 |
Data are mean (SD) unless otherwise specified. BMI indicates body mass index; CLcr, creatinine clearance; eGFR, estimated glomerular filtration rate; ESRD, end‐stage renal disease.