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RECRUITING
NCT06926413
PHASE1

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

Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

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).

Official title: An Open-label, Fixed-sequence Phase I Clinical Study Evaluating the Effect of Multiple Oral Doses of Aumolertinib on the Pharmacokinetics of Midazolam in Patients With Non-small Cell Lung Cancer (NSCLC)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2025-02-20

Completion Date

2025-10-31

Last Updated

2025-04-13

Healthy Volunteers

No

Interventions

DRUG

Aumolertinib;midazolam

Midazolam : 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. Aumolertinib : Starting from C1D1, the enrolled subjects will receive oral dose of aumolertinib 110 mg (55 mg/tablet, 2 tablets) once daily until the criteria for terminating treatment are met.

Locations (1)

Ethics Committee of the First Addiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China