drugset / Trial / NCT07697157
The Study on Effects of CYP3A and P-glycoprotein Inhibitor Itraconazole and CYP Enzyme Inducer Rifampin of HMPL-453 Tartrate Tablets
Non-randomizedCrossoverOpen-labelOther
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 \[Results of exploratory objectives analyses will be reported separately and not included in the clinical trial Study Report (CSR)\]
Timeline
- Start
- 2025-03-01
- Primary completion
- 2025-12-31
- Completion
- 2025-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HMPL-453 | Unknown | 100 mg | — |
| Subject | HMPL-453 | Unknown | 300 mg | — |
| Subject | Itraconazole | Small molecule | 200 mg | — |
| Subject | Rifampin | Small molecule | 600 mg | — |
Indications
No indication recorded.