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
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
Treatments tested in this trial
- HMPL-760
- Rabeprazole and HMPL-760
Treatment groups
24 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov