A Study on the Effect of Food and Proton Pump Inhibitor on the Pharmacokinetics of HMPL-760 Capsules

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: HMPL-760; Drug: Rabeprazole and HMPL-760

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Tianyun Li; Phone Number: (+86) 13037313645; Email: tianyunl@hutch-med.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200031
      • Shanghai Xuhui Central Hospital
      • Contact: Yanmei Liu, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Participants are fully aware of this study and voluntarily sign the ICF.
2. Male or female aged 18 to 45 years old (inclusive).
3. Participant's body mass index (BMI) at screening: 18 kg/m2 < BMI ≤ 29.9 kg/m2 and weight ≥ 50 kg for males and ≥ 45 kg for females.
4. Participant is willing and able to comply with the protocol in all aspects.

Exclusion Criteria:

1. Known history of any gastrointestinal surgery or any condition that could affect drug absorption (e.g., cholecystectomy, achlorhydria, peptic ulcer disease, gastric/intestinal surgery or history of resection; prior appendectomy or hernia repair is allowed).
2. Clinically significant disease within 8 weeks prior to the first dose or clinically significant infection within 4 weeks prior to the first dose.
3. Clinically significant abnormal findings in physical examination, vital signs, or laboratory tests at screening.
4. Systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg at screening.
5. Participants who smoked over 10 cigarettes daily within 3 months before screening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment A; All participants in treatment A will fast overnight for at least 10 hours prior to HMPL-760 dosing.	Drug: HMPL-760; 300 mg HMPL-760 will be administered orally once daily on Day 1, Day 6 and Day 11.
Experimental: Treatment B; All participants in treatment B will receive a standardized high-fat meal approximately 30 minutes before HMPL-760 administration	Drug: HMPL-760; 300 mg HMPL-760 will be administered orally once daily on Day 1, Day 6 and Day 11.
Experimental: Treatment C; All participants in treatment C will receive a standardized low-fat meal approximately 30 minutes before HMPL-760 administration	Drug: HMPL-760; 300 mg HMPL-760 will be administered orally once daily on Day 1, Day 6 and Day 11.
Experimental: Treatment D; All participants receive rabeprazole 20 mg orally QD 1 h before the breakfast on Day 15 and the morning of Day 16 to Day 20. Rabeprazole and HMPL-760 are orally administered concomitantly under fasted conditions on the morning of Day 21.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC 0-last	Area under the plasma concentration-time curve from time zero to the last time point t where the concentration could be accurately determined	Day 1 to Day 25
AUC 0-inf	Area under the plasma concentration-time curve from time 0 to infinity	Day 1 to Day 25
Cmax	Maximum plasma concentration	Day 1 to Day 25

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tmax	Time to Cmax	Day 1 to Day 25
tlag	Lag Time	Day 1 to Day 25
t1/2	Terminal elimination half-life	Day 1 to Day 25
Adverse events rate	Number of participants with treatment-related adverse events as assessed by CTCAE v6.0	Day 1 to Day 32(±1 day)
Laboratory tests	Number of participants with abnormal laboratory tests results	Day 1 to Day 32(±1 day)

Collaborators and Investigators

• Sponsor: Hutchmed

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: June 8, 2026
• First Submitted That Met QC Criteria: June 8, 2026
• First Posted (Actual): June 11, 2026

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 8, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Rabeprazole
• Other Study ID Numbers: 2026-760-00CH1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No