Table 1.
Baseline characteristics of the study population included in pharmacokinetic analysis
| Mild hepatic impairment (n = 8) | Healthy matched controls (n = 8)a | Moderate hepatic impairment (n = 8) | Healthy matched controls (n = 8)b | Moderate hepatic impairment (n = 3) | All groups combined (n = 35) | |
|---|---|---|---|---|---|---|
| Afatinib dose (mg) | 50 | 50 | 50 | 50 | 30 | 30/50 |
| Male [No. (%)] | 6 (75.0) | 6 (75.0) | 5 (62.5) | 5 (62.5) | 3 (100) | 25 (71.4) |
| Age (years) | 53.9 ± 9.0 | 55.9 ± 12.6 | 54.8 ± 9.0 | 53.1 ± 7.9 | 64.3 ± 6.1 | 55.3 ± 9.5 |
| White race [No. (%)] | 8 (100) | 8 (100) | 8 (100) | 8 (100) | 3 (100) | 35 (100) |
| Height (cm) | 178.8 ± 8.4 | 175.3 ± 8.4 | 171.6 ± 9.7 | 173.0 ± 11.7 | 180.0 ± 1.7 | 175.1 ± 9.3 |
| Body mass index (kg/m2) | 27.1 ± 4.0 | 28.4 ± 3.9 | 26.8 ± 3.8 | 26.0 ± 2.0 | 25.1 ± 5.6 | 26.9 ± 3.6 |
| Creatinine clearance (mL/min) | 91.4 ± 20.3 | 101.0 ± 32.9 | 87.3 ± 22.6 | 90.8 ± 14.2 | 75.5 ± 8.8 | 91.2 ± 22.5 |
Results presented as mean ± SD unless otherwise stated
aMatched to subjects with mild hepatic impairment
bMatched to subjects with moderate hepatic impairment