Effect of CYP3A4 inhibitor and induction on the pharmacokinetics and safety of FHND9041, a novel EGFR T790M inhibitor, in healthy Chinese

Table 3 Summary of Pharmacokinetic interaction statistical analysis for FHND9041 (Itraconazole + FHND9041 Group)

PK parameters	Monotherapy Phase		Co-administration Phase**		Mean ratio (combination/alone)	Mean ratio 90%CI	Intra-individual coefficient of variation (%)
PK parameters	N	Mean	N	Mean	Mean ratio (combination/alone)	Mean ratio 90%CI	Intra-individual coefficient of variation (%)
C_max (ng/mL)	15	26.2	13^ab	29.2	111.46	(103.26, 120.30)	11.00
AUC_{0 − last} (ng·h/mL)	14^a	1652	13^ab	2800	169.53	(156.21, 183.99)	11.78
AUC_{0 − inf} (ng·h/mL)	14^a	1808	13^ab	3041	168.25	(156.26, 181.15)	10.63

Note: a: Subject RD004 withdrew informed consent during the monotherapy phase and terminated the trial early, without proceeding to the co-administration phase. PK samples were collected only from pre-dose to 96 h post-dose during the monotherapy phase, which may underestimate AUC0-last and Tlast. These parameters were not included in the descriptive statistics. Additionally, since AUC_{_%Extrap} > 20%, λ_z and other parameters calculated based on λ_z (e.g., AUC_{0 − inf}, CL/F, V_z/F, t_1/2, etc.) could not be accurately calculated and were also excluded from the descriptive statistics
b: Subject RD010 had a pre-dose concentration of FHND9041 exceeding 5% of Cmax during the co-administration phase with Itraconazole. PK parameters for this subject during this phase were excluded from the descriptive statistics

ISSN: 2050-6511