drugset / Trial / NCT07348133
Study of Food Effect on Pharmacokinetics of HMPL-523 Acetate Tablets
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sovleplenib | Small molecule | 300 mg | — |
Indications
No indication recorded.