Table 3.

Ratio of Geometric LS Means and Corresponding 95%CIs for Mirogabalin PK Parameters Between Subjects With Varying Degrees of Renal Impairment and Those With Normal Renal Function

	Renal Classification According to CrCla
	Mild vs Normal (n = 6)	Moderate vs Normal (n = 6)	Severe vs Normal (n = 6)	ESRDb vs Normal (n = 6)
AUClast,c ng·h/mL	1.325 (0.921–1.905)	1.903 (1.324–2.736)	3.637 (2.530–5.230)	5.254 (3.654–7.553)
	P = .123	P = .001	P < .001	P < .001
AUC0‐inf,c ng·h/mL	1.324 (0.951–1.842)	1.873 (1.346–2.606)	3.531 (2.538–4.914)	8.335 (5.894–11.786)
	P = .093	P < .001	P < .001	P < .001
Cmax,c ng/mL	0.997 (0.700–1.420)	1.015 (0.712–1.445)	1.483 (1.041–2.113)	1.314 (0.923–1.873)
	P = .984	P = .933	P = .030	P = .124
CL/F,c L/h	0.755 (0.543–1.051)	0.534 (0.384–0.743)	0.283 (0.204–0.394)	0.120 (0.085–0.170)
	P = .093	P < .001	P < .001	P < .001

AUC_0–inf, area under the plasma concentration–time curve to infinity; AUC_last, area under the plasma concentration–time curve to the last quantifiable time; CI, confidence interval; CL/F, apparent total body clearance; C_max, maximum plasma concentration; CLr, renal clearance¹²; CrCl, creatinine clearance; ESRD, end‐stage renal disease.

^aRenal function groups, based on the Cockcroft‐Gault formula,¹² were: normal (estimated creatinine clearance [CrCl] > 80 mL/min/1.73 m²); mild impairment (50 mL/min/1.73 m² ≤ CrCl ≤ 80 mL/min/1.73 m²); moderate impairment (30 mL/min/1.73 m² ≤ CrCl < 50 mL/min/1.73 m²); severe impairment (CrCl < 30 mL/min/1.73 m²), and ESRD (patients undergoing hemodialysis, regardless of CrCl).

^b4‐Hour hemodialysis 24 hours after drug administration.

^cValues are presented as geometric LS mean ratios and 95%CIs.