Table 1.
Summary of Characteristics of Subjects Enrolled in the Hepatic Impairment Study.
| Demographic | Normal Hepatic Function | Moderate Hepatic Impairment | Severe Hepatic Impairment (N = 6) |
||
|---|---|---|---|---|---|
| Safety Evaluable Population (N = 14) |
PK Evaluable Population (N = 13) * |
Safety-Evaluable Population (N = 9) |
PK-Evaluable Population (N = 8) * |
||
| Age (years) | 56.9 (9.31) | 57.2 (9.65) | 57.4 (11.76) | 56.4 (12.09) | 60.8 (6.85) |
| Sex | |||||
| Male | 10 (71.4%) | 10 (76.9%) | 7 (77.8%) | 6 (75%) | 5 (83.3%) |
| Female | 4 (28.6%) | 3 (23.1%) | 2 (22.2%) | 2 (25%) | 1 (16.7%) |
| Race | |||||
| White | 10 (71.4%) | 9 (69.2%) | 9 (100%) | 8 (100%) | 6 (100%) |
| Black or African American | 4 (28.6%) | 4 (30.8%) | --- | --- | --- |
| Ethnicity | |||||
| Hispanic or Latino | 7 (50.0%) | 7 (53.8%) | 5 (55.6%) | 5 (62.5%) | 3 (50.0%) |
| Not Hispanic or Latino | 7 (50.0%) | 6 (46.2%) | 4 (44.4%) | 3 (37.5%) | 3 (50.0%) |
| Height (cm) | 172.15 (9.809) | 171.93 (10.174) | 169.96 (7.434) | 169.53 (7.321) | 172.18 (11.519) |
| Body Weight (kg) | 86.26 (15.288) | 85.92 (15.850) | 90.52 (17.360) | 88.5 (16.266) | 88.17 (21.017) |
| Body Mass Index (kg/m2) | 29.035 (3.9794) | 28.777 (3.9064) | 31.272 (4.9841) | 30.750 (4.7247) | 29.372 (3.9129) |
| Baseline Albumin (g/L) | 42.9 (3.17) | 43.2 (3.18) | 35.1 (3.69) | 35.0 (3.54) | 29.5 (4.59) |
N = number of subjects. Body mass index (kg/m2) = body weight (kg)/height (m)2. For continuous data, mean (SD) statistics are presented; for categorical data, n (%) statistics are presented. * One subject with normal hepatic function, who met the exclusion criterion for previous participation in another investigational study drug trial, and 1 subject with moderate hepatic impairment, who was dosed with 100 mg of pralsetinib instead of 200 mg, were excluded from the PK descriptive statistics and PK statistical analysis. Accordingly, 13 of the 14 subjects with normal hepatic function and eight of the nine subjects with moderate hepatic impairment were included in the PK statistical analysis.