Interaction Between CYP3A4 Regulators and New EGF

Abstract

Context The primary pathologic form of lung cancer is non-small cell carcinoma, and several clinical studies have shown that epidermal growth factor receptor tyrosinase inhibitors are more clinically effective and less hazardous than chemotherapy. Nanjing Chuangte Pharmaceutical Technology Co., Ltd. created the third-generation EGFR inhibitor FHND9041, an irreversible EGFR T790M mutation-selective small molecule kinase inhibitor. This research sought to determine how oral Rifampicin and oral Itraconazole capsules affected the pharmacokinetic profile, safety, and tolerability of a single oral dosage of FHND9041 capsules in healthy male Chinese participants. Patients and techniques A single-center, open-label, fixed-sequence design was used in this trial, with two parallel groups: Group 1 got 40 mg of FHND9041 together with itraconazole, while Group 2 received 80 mg of rifampicin. For a two-period trial, each group recruited 16 participants; the first period was monotherapy, while the second period involved co-administration. Every participant in this clinical study was a healthy adult male Chinese participant.
Findings The corrected geometric mean ratios (90% CI) of FHND9041 Cmax, AUC0 − last, and AUC0 − inf in healthy subjects following a single oral administration of 40 mg FHND9041 capsules were 111.46% (103.26 − 120.30%), 169.53% (156.21 − 183.99%), and 168.25% (156.26 − 181.15%) in comparison to the monotherapy phase. Cmax's 90% confidence interval was within the 80–125% range.