Health TrialsbyHealthPanel

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

ConditionHealthy Participants
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorHutchmed

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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.

Treatment groups

24 Participants
are divided into 4 treatment groups
Group A: Treatment AExperimental treatment 1 intervention
Group B: Treatment BExperimental treatment 1 intervention
Group C: Treatment CExperimental treatment 1 intervention
Group D: Treatment DExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Day 1 to Day 25
2

AUC 0-inf

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

Time frame
Day 1 to Day 25
3

Cmax

Maximum plasma concentration

Time frame
Day 1 to Day 25

Secondary outcomes

1

Tmax

Time to Cmax

Time frame
Day 1 to Day 25
2

tlag

Lag Time

Time frame
Day 1 to Day 25
3

t1/2

Terminal elimination half-life

Time frame
Day 1 to Day 25
4

Adverse events rate

Number of participants with treatment-related adverse events as assessed by CTCAE v6.0

Time frame
Day 1 to Day 32(±1 day)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hutchmed

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: