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A Study on the Effect of Food and Proton Pump Inhibitor on the Pharmacokinetics of HMPL-760 Capsules
Sponsor: Hutchmed
Summary
This is a single-center, open-label, randomized, four-period, six-sequence study with a planned enrollment of 24 healthy participants. The study consists of a screening period, a dosing period (Cycles 1, 2, 3, and 4), and a follow-up period. Screening must occur within 14 days prior to the first dose of study drug. Enrolled participants will be randomly assigned to one of 6 dosing sequences in the ratio of 1:1:1:1:1:1 to complete Cycles 1-3 dosing to evaluate the effect of different types of food on the PK of HMPL-760, and then to receive rabeprazole and HMPL-760 in Cycle 4 to assess the effect of PPI on the PK of HMPL-760 (see dosing sequence table for details).
Official title: An Open-Label, Randomized, Four-Period, Six-Sequence Phase I Study to Evaluate the Effect of Food and Proton Pump Inhibitor Rabeprazole on the Pharmacokinetics of HMPL-760 Capsules in Healthy Participants
Key Details
Gender
All
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2026-06
Completion Date
2026-12
Last Updated
2026-06-11
Healthy Volunteers
Yes
Conditions
Interventions
HMPL-760
300 mg HMPL-760 will be administered orally once daily on Day 1, Day 6 and Day 11.
Rabeprazole and HMPL-760
20 mg of rabeprazole will be administered orally once daily in the morning from Day 15 to Day 21, and a 300 mg oral dose of HMPL-760 will be administered concomitantly with rabeprazole on Day21.
Locations (1)
Shanghai Xuhui Central Hospital
Shanghai, Shanghai Municipality, China