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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | All participants in treatment A will fast overnight for at least 10 hours prior to HMPL-760 dosing. |
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| Treatment B | Experimental | All participants in treatment B will receive a standardized high-fat meal approximately 30 minutes before HMPL-760 administration |
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| Treatment C | Experimental | All participants in treatment C will receive a standardized low-fat meal approximately 30 minutes before HMPL-760 administration |
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| Treatment D | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HMPL-760 | Drug | 300 mg HMPL-760 will be administered orally once daily on Day 1, Day 6 and Day 11. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 1 to Day 25 |
| AUC 0-inf | Area under the plasma concentration-time curve from time 0 to infinity | Day 1 to Day 25 |
| Cmax | Maximum plasma concentration | Day 1 to Day 25 |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax | Time to Cmax | Day 1 to Day 25 |
| tlag | Lag Time | Day 1 to Day 25 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tianyun Li | Contact | (+86) 13037313645 | tianyunl@hutch-med.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Xuhui Central Hospital | Shanghai | Shanghai Municipality | 200031 | China |
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| ID | Term |
|---|---|
| D064750 | Rabeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| 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. |
|
| t1/2 |
Terminal elimination half-life |
| Day 1 to Day 25 |
| Adverse events rate | Number of participants with treatment-related adverse events as assessed by CTCAE v6.0 | Day 1 to Day 32(±1 day) |
| Laboratory tests | Number of participants with abnormal laboratory tests results | Day 1 to Day 32(±1 day) |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |