Clinical Trial

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

Completed Phase 1
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-01-09.
Status change: Recruiting → Completed 2026-02-11
Trial Details
NCT Number NCT07348133
Lead Sponsor Hutchmed
Conditions Healthy
Enrollment 18 participants
Start Date 2025-12-11
Primary Completion 2026-01-12 (estimated)
Study Completion 2026-02-06 (estimated)
Updated on ClinicalTrials.gov 2026-02-12