MedTrace Logo

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

NCT07697157 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-07-13

No results posted yet for this study

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 \[Results of exploratory objectives analyses will be reported separately and not included in the clinical trial Study Report (CSR)\]

Conditions

  • Health, Subjective

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

Sponsors & Collaborators

  • Hutchmed

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07697157 on ClinicalTrials.gov