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A Phase 1, Open-label, 4-Period, Randomized 6-Sequence Study to Evaluate the Effect of Food and Rabeprazole, a Proton Pump Inhibitor, on the Pharmacokinetics of HMPL-453 in Healthy Volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fast overnight | Experimental | Subjects in treatment A will administered HMPL-453 at fast overnight condition. |
|
| high-fat meal | Experimental | Subjects in treatment B will administered HMPL-453 at high-fat meal condition. |
|
| low-fat meal | Experimental | Subjects in treatment C will administered HMPL-453 at low-fat meal condition. |
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| rabeprazole | Experimental | Subjects in treatment D will administered rabeprazole combined with HMPL-453 at low-fat meal condition hour prior to receiving a standardized low-fat meal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HMPL-453 | Drug | 300 mg HMPL-453 |
|
| Measure | Description | Time Frame |
|---|---|---|
| PK parameter for HMPL-453: AUC0-t | Area under the concentration time curve from time 0 to the last measurable concentration | Day 1 to Day 33 |
| PK parameter for HMPL-453: AUC0-inf | Area under the concentration time curve from time 0 extrapolated to infinity | Day 1 to Day 33 |
| PK parameter for HMPL-453: Cmax | Maximum observed plasma concentration | Day 1 to Day 33 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of safety procedures findings | Any untoward medical occurrence associated with the study drug | Day 1 to Day 33 |
| PK parameter for HMPL-453: tmax,t1/2 | Time to reach the maximum observed plasma concentration, elimination half-life |
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Inclusion Criteria:
Exclusion Criteria:
18.Needle sickness, blood sickness or difficulty in collecting venous blood. 19.The volunteer is allergic to any of the study drugs (or its excipients) to be given in this study.
20.A female participant is pregnant, lactating, or breastfeeding. 21.Any other medical condition judged by the investigator would make the patients unsuitable to participate in this study.
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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 |
|---|---|
| D018281 | Cholangiocarcinoma |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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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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Open-label, 4-Period, Randomized 6-Sequence Study
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| Rabeprazole | Drug | 20 mg of rabeprazole will be administered by mouth once daily. |
|
| Day 1 to Day 33 |
| D009369 | Neoplasms |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |