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Study of Food Effect on Pharmacokinetics of HMPL-523 Acetate Tablets

NCT07348133 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-02-12

No results posted yet for this study

Summary

This is a single-center, open-label, randomized, three-period, six-sequence study to evaluate the effect of food (high-fat and low-fat) on the PK of HMPL-523. In this study, 18 healthy Chinese participants are planned to be enrolled, randomized in a ratio of 1:1:1:1:1:1 to one of 6 dosing sequences (see dosing sequence table for details), and administered once per cycle for 3 cycles, with a washout period of at least 7 days. The study consists of a screening/baseline period, a dosing period (three cycles), and a follow-up period.

Conditions

  • Healthy

Interventions

DRUG

HMPL-523

The 3 cycles of each sequence consist of 3 dietary conditions, i.e., fasting (A), standard high-fat breakfast (B), and standard low-fat breakfast (C). Participants will receive a single oral dose of HMPL-523 acetate tablets 300 mg on Day 1 of each cycle.

Sponsors & Collaborators

  • Hutchmed

    lead INDUSTRY

Principal Investigators

  • Wei Zhao, Doctor · Shandong First Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-11
Primary Completion
2026-01-12
Completion
2026-02-06

Countries

  • China

Study Locations

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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 NCT07348133 on ClinicalTrials.gov