Table 3.

Pharmacokinetic parameters (adjusted for body weight) of dotinurad in plasma, with comparison between groups

Parameters (unit)	Normal hepatic function (n = 6)	Mild hepatic impairment (n = 6)
	Mean ± SD	Mean ± SD	Geometric mean ratioa
			Point estimate	Two-sided 90% CI
Cmax (ng kg/mL)	20,665.9 ± 1450.3	19,054.3 ± 3867.7	0.908	0.720–1.147
AUC0–48 (ng kg h/mL)	277,096.0 ± 22,379.2	265,029.3 ± 58,564.3	0.940	0.710–1.245
AUC0–inf (ng kg h/mL)	290,502.3 ± 23,625.3	279,743.3 ± 67,960.8	0.943	0.697–1.275
CLtot/F (L/h/kg)	0.0139 ± 0.0012	0.0150 ± 0.0035	1.061	0.784–1.435
Vd/F (L/kg)	0.216 ± 0.021	0.220 ± 0.032	1.011	0.834–1.226

Parameters (unit)	Moderate hepatic impairment (n = 9)			Severe hepatic impairment (n = 3)
	Mean ± SD	Geometric mean ratioa		Mean ± SD	Geometric mean ratioa
		Point estimate	Two-sided 90% CI		Point estimate	Two-sided 90% CI
Cmax (ng kg/mL)	16,994.2 ± 4765.3	0.792	0.640–0.980	18,181.2 ± 3757.9	0.869	0.653–1.155
AUC0–48 (ng kg h/mL)	252,948.5 ± 84,717.2	0.868	0.672–1.122	258,929.9 ± 94,795.0	0.889	0.630–1.255
AUC0–inf (ng kg h/mL)	268,605.8 ± 97,755.3	0.872	0.662–1.149	270,778.5 ± 105,677.4	0.881	0.609–1.275
CLtot/F (L/h/kg)	0.0169 ± 0.0065	1.146	0.870–1.510	0.0167 ± 0.0077	1.135	0.784–1.642
Vd/F (L/kg)	0.247 ± 0.062	1.121	0.940–1.337	0.222 ± 0.056	1.012	0.800–1.282

AUC_0–inf area under the plasma concentration−time curve from time 0 to infinity, AUC_0–48 area under the plasma concentration−time curve from time 0 to 48 h, CI confidence interval, CL_tot/F total clearance/fraction of dose absorbed, C_max maximum plasma concentration, SD standard deviation, Vd/F distribution volume/fraction of dose absorbed

^aThe mean was converted to a common logarithm and then the geometric mean ratio was calculated using the following formula:

Geometric mean ratio = 10^{Mean difference}

Mean difference = (mean in the target group) − (mean in the normal hepatic function group)