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

June 8, 2026 updated by: Hutchmed

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
AUC 0-last
Time Frame: Day 1 to Day 25
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
Time Frame: Day 1 to Day 25
Area under the plasma concentration-time curve from time 0 to infinity
Day 1 to Day 25
Cmax
Time Frame: Day 1 to Day 25
Maximum plasma concentration
Day 1 to Day 25

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Tmax
Time Frame: Day 1 to Day 25
Time to Cmax
Day 1 to Day 25
tlag
Time Frame: Day 1 to Day 25
Lag Time
Day 1 to Day 25
t1/2
Time Frame: Day 1 to Day 25
Terminal elimination half-life
Day 1 to Day 25
Adverse events rate
Time Frame: Day 1 to Day 32(±1 day)
Number of participants with treatment-related adverse events as assessed by CTCAE v6.0
Day 1 to Day 32(±1 day)
Laboratory tests
Time Frame: Day 1 to Day 32(±1 day)
Number of participants with abnormal laboratory tests results
Day 1 to Day 32(±1 day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hutchmed

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 8, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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