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This is a phase 1, randomised, open-label, three-way, three-period, crossover relative bioavailability study to assess the pharmacokinetics of HRS-6209 capsules (old and new formulation) in healthy participants. The effect of high-fat food on the pharmacokinetics of HRS-6209 in new formulation will also be evaluated. A total of 21 healthy participants will be randomised to receive a single oral dose of HRS-6209 in three treatment periods: old formulation (fasted); new formulation (fasted); new formulation (fasted).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants receiving treatment sequence A+C+B | Experimental | Treatment sequence A = HRS-6209 capsule old formulation given in fasted state; Treatment sequence B = HRS-6209 capsule new formulation given in fasted state; Treatment sequence C = HRS-6209 capsule new formulation given in fed state. |
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| Participants receiving treatment sequence C+B+A | Experimental | Treatment sequence A = HRS-6209 capsule old formulation given in fasted state; Treatment sequence B = HRS-6209 capsule new formulation given in fasted state; Treatment sequence C = HRS-6209 capsule new formulation given in fed state. |
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| Participants receiving treatment sequence B+A+C | Experimental | Treatment sequence A = HRS-6209 capsule old formulation given in fasted state; Treatment sequence B = HRS-6209 capsule new formulation given in fasted state; Treatment sequence C = HRS-6209 capsule new formulation given in fed state. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-6209 Capsule (old formulation) | Drug | Oral administration after fasting. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration time curve (AUC) | pharmacokinetics (PK) parameter of HRS-6209. | Day 1 - Day 9. |
| Maximum Plasma Concentration (Cmax) | pharmacokinetics (PK) parameter of HRS-6209. | Day 1 - Day 9. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events / serious adverse events (AEs / SAEs) | Safety assessment, graded as per CTCAE 6.0. | Up to 1 month. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian Li | Contact | +86-0518-82342973 | jian.li.jl611@hengrui.com | |
| Qiushi Xie | Contact | +86-0518-82342973 | qiushi.xie.qx8@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuzhou University Affiliated Provincial Hospital | Fuzhou | Fujian | 350001 | China |
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This is an open-label, randomized, 3-way, 3-period crossover study.
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| HRS-6209 Capsule (new formulation) | Drug | Oral administration after fasting/high-fat meal. |
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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