Table 7.
Statistical summary of hepatic impairment comparisons
| Molecule and parameter | Geometric mean ratio (90 % CI) | |
|---|---|---|
| Mild hepatic impairmenta | Moderate hepatic impairmentb | |
| Enzalutamide | ||
| AUC∞ | 1.05 (0.79–1.39) | 1.29 (1.01–1.65) |
| C max | 1.24 (0.92–1.66) | 0.89 (0.69–1.16) |
| N-desmethyl enzalutamide | ||
| AUC∞ | 1.18 (0.90–1.54) | 1.07 (0.85–1.35) |
| C max | 1.26 (0.92–1.72) | 0.85 (0.65–1.11) |
| Enzalutamide + N-desmethyl enzalutamide | ||
| AUC∞ | 1.13 (0.89–1.43) | 1.18 (0.96–1.45) |
| C max | 1.23 (0.92–1.66) | 0.89 (0.69–1.15) |
| Carboxylic acid metabolite | ||
| AUClast c | 1.14 (0.71–1.81) | 0.57 (0.38–0.86) |
| C max | 1.30 (0.85–1.99) | 0.63 (0.44–0.91) |
AUC ∞ area under the plasma concentration–time curve from time zero to infinity, AUC last area under the plasma concentration–time curve from time zero to the last quantifiable concentration, CI confidence interval, C max maximum plasma concentration
aBased on a comparison of n = 6 subjects with mild hepatic function and n = 6 subjects with normal hepatic function after a single oral dose of enzalutamide 160 mg
bBased on a comparison of n = 8 subjects with moderate hepatic function and n = 8 subjects with normal hepatic function after a single oral dose of enzalutamide 160 mg
cComparisons were based on AUClast because the sampling period was of insufficient duration to calculate AUC∞