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

NCT07643272 | Active Not Recruiting Phase 1

• 1 other identifier: 2026-760-00CH1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Tmax

  Day 1 to Day 25

• tlag

  Day 1 to Day 25

• t1/2

  Day 1 to Day 25

• Adverse events rate

  Day 1 to Day 32(±1 day)

• Laboratory tests

  Day 1 to Day 32(±1 day)

Study Arms (4)

Treatment A- HMPL-760

EXPERIMENTAL

All participants in treatment A will fast overnight for at least 10 hours prior to HMPL-760 dosing.

Drug: HMPL-760

Treatment B- HMPL-760

EXPERIMENTAL

All participants in treatment B will receive a standardized high-fat meal approximately 30 minutes before HMPL-760 administration

Drug: HMPL-760

Treatment C- HMPL-760

EXPERIMENTAL

All participants in treatment C will receive a standardized low-fat meal approximately 30 minutes before HMPL-760 administration

Drug: HMPL-760

Treatment D- Rabeprazole and HMPL-760

EXPERIMENTAL

All participants receive rabeprazole 20 mg orally QD(Quaque Die) 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

Interventions

HMPL-760 DRUG

300 mg HMPL-760 will be administered orally once daily on Day 1, Day 6 and Day 11.

Treatment A- HMPL-760; Treatment B- HMPL-760; Treatment C- HMPL-760

Rabeprazole and HMPL-760 DRUG

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.

Treatment D- Rabeprazole and HMPL-760

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants are fully aware of this study and voluntarily sign the ICF.
• Male or female aged 18 to 45 years old (inclusive).
• 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.
• Participant is willing and able to comply with the protocol in all aspects.

You may not qualify if:

• 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).
• Clinically significant disease within 8 weeks prior to the first dose or clinically significant infection within 4 weeks prior to the first dose.
• Clinically significant abnormal findings in physical examination, vital signs, or laboratory tests at screening.
• Systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg at screening.
• Participants who smoked over 10 cigarettes daily within 3 months before screening.

Sponsors & Collaborators

• Hutchmed: lead

Study Sites (1)

Shanghai Xuhui Central Hospital

Shanghai, Shanghai Municipality, 200031, China

Location

MeSH Terms

Interventions

Rabeprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 11, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)