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NCT Number: NCT07643272

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

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Healthy Participants

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Shanghai Xuhui Central Hospital

Shanghai, Shanghai Municipality, 200031, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

HMPL-760

Drug

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

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.

Primary outcomes

  1. 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

  2. AUC 0-inf

    Time frame: Day 1 to Day 25

    Area under the plasma concentration-time curve from time 0 to infinity

  3. Cmax

    Time frame: Day 1 to Day 25

    Maximum plasma concentration

Secondary outcomes

  1. Tmax

    Time frame: Day 1 to Day 25

    Time to Cmax

  2. tlag

    Time frame: Day 1 to Day 25

    Lag Time

  3. t1/2

    Time frame: Day 1 to Day 25

    Terminal elimination half-life

  4. 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

  5. Laboratory tests

    Time frame: Day 1 to Day 32(±1 day)

    Number of participants with abnormal laboratory tests results

Sponsors and collaborators

Lead sponsor

Hutchmed

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 11, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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