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A single center, open-label, fixed sequence Phase 1, drug-drug interaction (DDI) study in male healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | SPH3127 tablet, Itraconazole |
|
| Cohort 2 | Experimental | SPH3127 tablet, Rifampin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPH3127 tablet | Drug | 100mg once daily on Day 1 and Day 8 |
| |
| Itraconazole |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum serum concentration (Cmax) of SPH3127 | To characterize the PK (Pharmacokinetics) of SPH3127 | Up to 14 days |
| Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-Last) of SPH3127 | To characterize the PK (Pharmacokinetics) of SPH3127 | Up to 14 days |
| Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-infinity) of SPH3127 | To characterize the PK (Pharmacokinetics) of SPH3127 | Up to 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse event. | Adverse events, 12-lead ECG, clinical laboratory tests, physical examination and vital signs. | Up to 42 days |
| Time of maximum serum concentration (Tmax) SPH3127 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qin Yu | West China Second University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Second University Hospital, Sichuan University | Chengdu | Sichuan | 610044 | China |
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| ID | Term |
|---|---|
| C000709209 | SPH3127 |
| D017964 | Itraconazole |
| D012293 | Rifampin |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
200mg once daily from Day 3 to Day10. |
|
| SPH3127 tablet | Drug | 200mg once daily on Day 1 and Day 12. |
|
| Rifampin | Drug | 600mg once daily from Day 3 to Day13. |
|
To characterize the PK (Pharmacokinetics) of SPH3127
| Up to 14 days |
| Half-life (t1/2) of SPH3127 | To characterize the PK (Pharmacokinetics) of SPH3127 | Up to 14 days |
| Apparent oral clearance (CL/F) of SPH3127 | To characterize the PK (Pharmacokinetics) of SPH3127 | Up to 14 days |
| Apparent oral volume of distribution (Vz/F) of SPH3127 | To characterize the PK (Pharmacokinetics) of SPH3127 | Up to 14 days |
| 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 |