This is an open-label, fixed-sequence Phase I clinical trial to evaluate the effect of HS-10504 on the pharmacokinetics of midazolam (CYP3A4 substrate) in patients with EGFR mutation-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have experienced disease progression during or after treatment with EGFR-TKIs.
Histologically or cytologically confirmed locally advanced or metastatic NSCLC
Disease progression or intolerance to prior third-generation EGFR TKI therapy in patients with mNSCLC
Confirmed EGFR mutation positivity in participants before enrollment.
At least one target lesion according to RECIST 1.1
Prior or current treatment with a fourth-generation EGFR tyrosine kinase inhibitor.
Use of strong/moderate inhibitors or strong/moderate inducers of CYP3A4, CYP3A5, CYP2C8, and/or CYP2D6, or narrow therapeutic index drugs that are sensitive substrates of CYP3A4, CYP3A5, P-gp, and BCRP within 14 days or 5 half-lives (whichever is longer) prior to the first dose of investigational product; or need to continue these medications during the study period.
Use of drugs that affect gastric acid secretion or intragastric pH within 7 days prior to the first dose of investigational product.
Currently receiving treatment with drugs known to prolong the QT interval or that may cause torsade de pointes; or need to continue these medications during the study period
Single group
HS-10504； midazolam
DrugHS-10504：Participants receive HS-10504 tablets 400 mg (100 mg/tablet, 4 tablets) once daily Midazolam：Participants receive a single oral dose of midazolam oral solution 1 mg (2 mg/mL, 0.5 mL) on C0D1 and C2D20, respectively。
Evaluation of PK parameters of Midazolam: Cmax
To evaluate the Cmax of Midazolam administered alone and in combination with HS-10504
Evaluation of PK parameters of Midazolam: AUC0-t
To evaluate the AUC0-t of Midazolam administered alone and in combination with HS-10504
Evaluation of PK parameters of Midazolam: AUC0-∞
To evaluate the AUC0-∞ of Midazolam administered alone and in combination with HS-10504
Evaluation of PK parameters of Midazolam: Tmax
To evaluate the Tmax of Midazolam administered alone and in combination with HS-10504
Evaluation of PK parameters of Midazolam: t1/2z
To evaluate the t1/2z of Midazolam administered alone and in combination with HS-10504
Evaluation of PK parameters of Midazolam: λz
To evaluate the λz of Midazolam administered alone and in combination with HS-10504
Evaluation of PK parameters of Midazolam: CLz/F
To evaluate the CLz/F of Midazolam administered alone and in combination with HS-10504
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