A Study Evaluating the Effect of Aumolertinib on the Pharmacokinetics of Midazolam in Patients With NSCLC

This is an open-label, fixed-sequence Phase I clinical study that evaluates the effect of multiple doses of aumolertinib on the pharmacokinetics of midazolam (CYP 3A4 probe substrate) in sensitive EGFR (Epidermal Growth Factor Receptor) mutation-harboring patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). The study includes D1 (Day 1)-D2 (Day 2) of run-in period, C1D1 (Cycle 1 Day 1)-C1D21 (Cycle 1 Day 21) and C2D1 (Cycle 2 Day 1)-C2D2 (Cycle 2 Day 2). The enrolled subjects will receive a single oral dose of midazolam 2 mg (2 mg/mL, 1 mL) on D1 of the run-in period and on C2D1; and receive oral dose of aumolertinib 110 mg (55 mg/tablet, 2 tablets) once daily from C1D1 to C2D2.