Healthy Participants
Conditions
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).
Interventions
DRUGHMPL-760
300 mg HMPL-760 will be administered orally once daily on Day 1, Day 6 and Day 11.
DRUGRabeprazole 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.
Sponsors
Hutchmed
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC 0-last | 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 |
| AUC 0-inf | Day 1 to Day 25 | Area under the plasma concentration-time curve from time 0 to infinity |
| Cmax | Day 1 to Day 25 | Maximum plasma concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tmax | Day 1 to Day 25 | Time to Cmax |
| tlag | Day 1 to Day 25 | Lag Time |
| t1/2 | Day 1 to Day 25 | Terminal elimination half-life |
| Adverse events rate | Day 1 to Day 32(±1 day) | Number of participants with treatment-related adverse events as assessed by CTCAE v6.0 |
| Laboratory tests | Day 1 to Day 32(±1 day) | Number of participants with abnormal laboratory tests results |
Countries
China
Outcome results
None listed