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This study is a single-center, randomized, open-label, single-dose, two-period, two-treatment crossover trial aimed at evaluating the pharmacokinetic (PK) profiles and safety of SY-5007 tablets administered orally to healthy subjects in both fasting and fed states in China.
The study consists of two parts: a pilot study and a formal study. The pilot study involves four healthy subjects who will receive a single dose of SY-5007 80 mg after a meal (high-fat meal) for Period 1 and on an empty stomach for Period 2, with observation and PK blood sample collection.
The formal study plans to enroll 24 healthy subjects, divided into Groups A and B, each with 12 subjects, receiving a dose of 160 mg. Group A will receive the drug on an empty stomach for Period 1, followed by administration after a meal (high-fat meal) for Period 2, while Group B will follow the reverse sequence. Both groups will adopt a two-period, two-treatment crossover design with a washout period of 7 days. If the pilot study results show a significant impact of food on the PK characteristics or safety of SY-5007, subsequent trial protocols may be adjusted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fasted dosing followed by fed dosing | Experimental | A single oral dose in the fasted state at Period 1 followed by fed dosing at Period 2 |
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| Fed dosing followed by fasted dosing | Experimental | A single oral dose in the fed state at Period 1 followed by fasted dosing at Period 2 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SY-5007 | Drug | SY-5007 160 mg, Tablets, 2 discrete single doses separated by 7-days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax for SY-5007 | Defined as maximum observed plasma concentration | Day 1-Day 15 |
| Tmax for SY-5007 | Defined as time to maximum plasma concentration | Day 1-Day 15 |
| AUC0-t for SY-5007 | Defined as area under the single-dose plasma concentration-time curve from Hour 0 to the last quantifiable measurable plasma concentration | Day 1-Day 15 |
| AUC0-∞ for SY-5007 | Defined as area under the single-dose plasma concentration-time curve from Hour 0 to infinity | Day 1-Day 15 |
| t½ for SY-5007 | Defined as apparent plasma terminal phase disposition half-life | Day 1-Day 15 |
| CL/F for SY-5007 | Defined as apparent total body clearance | Day 1-Day 15 |
| Vz/F for SY-5007 | Defined as apparent oral Volume of distribution | Day 1-Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of SY-5007 | AE (adverse event) will be summarized by type and severity | Day 1-Day 22 |
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Inclusion Criteria:
Subjects must meet all of the following inclusion criteria to be eligible for participation in this study:
Exclusion Criteria:
Subjects will be ineligible for this study if they meet any of the following criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yinghui Sun, Dr | Contact | 86-10-88858616 | yhsun@centaurusbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Yinghui Sun, Dr | Shouyao Holdings (Beijing) Co. LTD | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan University | Chengdu | Sichuan | 610041 | China |
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| SY-5007 | Drug | SY-5007 160 mg, Tablets, 2 discrete single doses separated by 7-days |
|