Table 1.
Demographic and Baseline Characteristics of the Pharmacokinetic Patient Population
| Variable | Combined | AVL‐292‐004 | AVL‐292‐003 |
|---|---|---|---|
| Demographics | |||
| Sex, n (%) | |||
| Male | 87 (60%) | 23 (72%) | 64 (57%) |
| Female | 58 (40%) | 9 (28%) | 49 (43%) |
| Race, n (%) | |||
| Asian | 2 (1.4%) | 0 (0%) | 2 (2%) |
| Black | 20 (13.8%) | 14 (44%) | 6 (5%) |
| Other | 2 (1.4%) | 0 (0%) | 2 (2%) |
| White | 121 (83.4%) | 18 (56%) | 103 (91%) |
| Ethnicity, n (%) | |||
| Hispanic or Latino | 15 (10.3%) | 9 (28%) | 6 (5%) |
| Not Hispanic or Latino | 130 (89.7%) | 23 (72%) | 107 (95%) |
| Patient characteristics, median (range) | |||
| Age, year | 62.0 (20.0, 89.0) | 40.5 (20.0, 65.0) | 66.0 (29.0, 89.0) |
| Body weight, kg | 79.5 (49.9, 128.4) | 80.0 (55.1, 108.7) | 79.4 (49.9, 128.4) |
| Height, cm | 170.0 (149.0, 200.0) | 171.4 (153.0, 187.2) | 169.4 (149.0, 200.0) |
| Body mass index, kg/m2 | 27.0 (19.0, 41.0) | 27.5 (20.5, 32.9) | 26.8 (19.0, 41.0) |
| Hepatic function, median (range) | |||
| Albumin, g/dL | 4.3 (2.6, 5.0) | 4.2 (3.5, 4.8) | 4.3 (2.6, 5.0) |
| Alkaline phosphatase, IU/L | 77.0 (37.0, 294.0) | 62.0 (39.0, 103.0) | 82.0 (37.0, 294.0) |
| Alanine aminotransferase IU/L | 19.0 (4.0, 87.0) | 20.0 (12.0, 36.0) | 18.0 (4.0, 87.0) |
| Aspartate aminotransferase, IU/L | 22.0 (8.0, 70.0) | 23.0 (16.0, 30.0) | 22.0 (8.0, 70.0) |
| Total bilirubin, mg/dL | 0.4 (0.1–1.3) | 0.6 (0.4–1.3) | 0.3 (0.1–1.2) |
| Lactase dehydrogenase IU/L | 190.0 (95.0, 2000.0) | 133.0 (98.0, 173.0) | 229.0 (95.0, 2000.0) |
| Total protein, g/dL | 6.7 (4.6, 9.9) | 7.5 (6.5, 8.1) | 6.5 (4.6, 9.9) |
| Renal function, median (range) | |||
| Serum creatinine, mg/dL | 0.93 (0.45, 1.65) | 0.93 (0.60, 1.34) | 0.94 (0.45, 1.65) |
| Creatinine clearance, mL/min | 86.3 (31.0, 193.3) | 112.0 (70.7, 157.8) | 77.9 (31.0, 193.3) |