Table 1.
Demographics of Study Participants
| Moderate Hepatic Impairment | Matched Healthy Controlsa | Total | |
|---|---|---|---|
| Demographic | (n = 8) | (n = 8) | (n = 16) |
| Sex, n (%) | |||
| Female | 2 (25) | 2 (25) | 4 (25) |
| Male | 6 (75) | 6 (75) | 12 (75) |
| Age (y), mean (SD) | 60.3 (3.20) | 56.9 (6.17) | 58.6 (5.06) |
| BMI (kg/m2), mean (SD) | 29.3 (3.78) | 29.2 (4.17) | 29.2 (3.85) |
| Race/ethnicity, n (%) | |||
| Black/African American | 2 (25) | 2 (25) | 4 (25) |
| White/Caucasian/European heritage | 6 (75) | 6 (75) | 12 (75) |
| Child‐Pugh total score, n (%) | |||
| 7 | 3 (37.5) | — | — |
| 8 | 3 (37.5) | — | — |
| 9 | 2 (25.0) | — | — |
| Plasma albumin (g/L), mean (SD) | 36.0 (6.5) | 43.3 (5.1) | — |
| AAG (g/L), mean (SD) | 0.73 (0.45) | 0.92 (0.15) | — |
| ALP (IU/L), mean (SD) | 141.5 (73) | 87.9 (16) | — |
| ALT (IU/L), mean (SD) | 45.5 (27) | 21.9 (5.2) | — |
| AST (IU/L), mean (SD) | 61.3 (32) | 24.1 (4.4) | — |
| Direct bilirubin (µM), mean (SD) | 12.4 (6.6) | 3.4 (0.9) | — |
| Bilirubin (µM), mean (SD) | 24.4 (10.6) | 9.4 (2.9) | — |
All laboratory values reported were conducted at screening (30 days prior to first dose).
AAG, alpha‐1 acid glycoprotein; ALT, alanine aminotransferase; ALP, alkaline phosphatase; AST, aspartate aminotransferase; BMI, body mass index; SD, standard deviation.
a
Healthy controls were matched to participants with hepatic impairment by sex, age (±10 years), and BMI (±25%).