Clinical Trial

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

Completed Phase 1
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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 \[Results of exploratory objectives analyses will be reported separately and not included in the clinical trial Study Report (CSR)\]
Trial Details
NCT Number NCT07697157
Lead Sponsor Hutchmed
Conditions Health, Subjective
Enrollment 40 participants
Start Date 2025-03-01
Primary Completion 2025-12-31 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-13