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