drugset / Trial / NCT07348133

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

NCT07348133

Phase 1 Completed 18 enrolled Hutchmed
RandomizedSequentialOpen-labelTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Sovleplenib Small molecule 300 mg

Indications

No indication recorded.