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This study is a single-center, open-lable and fixed sequence test conducted in healthy subjects to evaluate the pharmacokinetic effects of Itraconazole and Rifampicin on a single dose of SY-5007 Oral administration. It is planned to enroll 28 healthy subjects and assign them to two parallel test groups, Group A (SY-5007 combined with Itraconazole) and Group B (SY-5007 combined with Rifampicin).
A total of 28 evaluable healthy male subjects will be enrolled in this study. The subjects will be divided into two groups, A and B, with 14 people in each group.
In the itraconazole study (Group A), patients received single-dose SY-5007 80 mg on Day 1 and Day 11 and itraconazole 200 mg once or twice daily on Day 8-Day 18 orally.
In the rifampicin study (Group B), patients received single-dose SY-5007 160mg on Day 1 and Day 16 and rifampicin 600 mg once daily on Day 8-Day 21 orally.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A, Treatment Sequence (SY-5007-SY-5007/Itraconazole) | Experimental | SY-5007 80mg, tablets, once daily on Day 1 and Day 11 before meal; Itraconazole 200mg, once or twice daily from Day 8 to Day 18. |
|
| Group B, Treatment Sequence (SY-5007-SY-5007/Rifampin) | Experimental | SY-5007 160mg, tablets, once daily on Day 1 and Day 16 before meal, Rifampicin 600mg, once daily from Day 8 to Day 21. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SY-5007 | Drug | SY-5007 80 mg, Tablets, 2 discrete single doses at Day 1 and Day 11 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax for SY-5007 | Defined as maximum observed plasma concentration | Day 1-Day 22 |
| Tmax for SY-5007 | Defined as time to maximum plasma concentration | Day 1-Day 22 |
| 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 22 |
| AUC0-∞ for SY-5007 | Defined as area under the single-dose plasma concentration-time curve from Hour 0 to infinity | Day 1-Day 22 |
| t½ for SY-5007 | Defined as apparent plasma terminal phase disposition half-life | Day 1-Day 22 |
| CL/F for SY-5007 | Defined as apparent total body clearance | Day 1-Day 22 |
| Vz/F for SY-5007 | Defined as apparent oral Volume of distribution | Day 1-Day 22 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of SY-5007 | AE (adverse event) will be summarized by type and severity | Up to 29 days |
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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 | 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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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| D012293 | Rifampin |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Itraconazole | Drug | Itraconazole 200 mg, Capsules, Day 8-Day 18 |
|
| SY-5007 | Drug | SY-5007 160 mg, Tablets, 2 discrete single doses at Day 1 and Day 16 |
|
| Rifampin | Drug | Rifampin 600 mg, Capsules, Day 8-Day 21 |
|
| D010879 |
| Piperazines |
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |