TABLE 3

Summary of statistical analysis derived nemiralisib pharmacokinetic parameters following inhalation administration of nemiralisib alone and inhaled nemiralisib with oral itraconazole

PK Parameter	Treatment	N	n	Adjusted Geometric Mean (90% CI)	Ratio of Adjusted Geometric Means (90% CI), Nemiralisib vs. Nemiralisib with Itraconazole	Mean Squared Error
AUC_0-inf (h*pg/ml)	Nemiralisib 100 µg single dose	20	20	3199.0 (2874.7, 3559.9)	2.01 (1.81, 2.22)	0.0253
AUC_0-inf (h*pg/ml)	Nemiralisib 100 µg single dose with itraconazole 200 mg repeat dose	20	14	6413.4 (5695.9, 7221.3)	2.01 (1.81, 2.22)	0.0253
C_max (pq/ml)	Nemiralisib 100 µg single dose	20	20	478.7 (416.4, 550.3)	0.802 (0.690, 0.933)	0.0762
C_max (pq/ml)	Nemiralisib 100 µg single dose with itraconazole 200 mg repeat dose	20	20	384.0 (334.0, 441.4)	0.802 (0.690, 0.933)	0.0762

AUC_0-inf, area under the plasma concentration-time curve time zero (predose) extrapolated to infinite time; CI, confidence interval; C_max, maximum observed plasma concentration; N, number of subjects; n, number of evaluable subjects.