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COMPLETED
NCT07697157
PHASE1

The Study on Effects of CYP3A and P-glycoprotein Inhibitor Itraconazole and CYP Enzyme Inducer Rifampin of HMPL-453 Tartrate Tablets

Sponsor: Hutchmed

View on ClinicalTrials.gov

Summary

Primary objective: 1. To evaluate the effect of Itraconazole ( CYP3A and P-gp inhibitors) on HMPL-453 pharmacokinetics(PK) in healthy subjects 2. To evaluate the effect of Rifampin (CYP enzyme inducer) on HMPL-453 pharmacokinetics (PK) in healthy subjects Secondary objectives: To evaluate the safety of HMPL-453 with and without itraconazole or rifampin following a low-fat meal in healthy subjects Exploratory objectives: 1. Assess cholesterol and 4β- hydroxycholesterol in plasma CYP3A4 Biomarker Concentration Levels ; 2. Explore proarrhythmic effect of HMPL-453 \[Results of exploratory objectives analyses will be reported separately and not included in the clinical trial Study Report (CSR)\]

Official title: An Open-Label, Two-Part, Two-Period, Fixed Sequence Crossover I Study to Evaluate the Effect of CYP3A and P- Glycoprotein Inhibitor Itraconazole and CYP Enzyme Inducer Rifampicin on the Pharmacokinetics of HMPL-453 Tartrate Tablets in Healthy Subjects

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-03-01

Completion Date

2025-12-31

Last Updated

2026-07-13

Healthy Volunteers

Yes

Interventions

DRUG

HMPL-453 with Itraconazole

HMPL-453: 100mg, D1、D14; Itraconazole: 400mg, D10;200mg,D11-D22

DRUG

HMPL-453 with Rifampin

HMPL-453: 300mg, D1、D16; Rifampin: 600mg, D10-D24

Locations (1)

yijishan Hospital

Wuhu, Anhui, China