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This study will be a 2-period study conducted with 14 healthy male or female subjects. Subjects will be administered surufatinib alone in Period 1 and in combination with itraconazole in Period 2.
This study will be a single center, open label, fixed-sequence crossover, 2-period study conducted with 14 healthy male or female subjects. Subjects will be administered surufatinib alone in Period 1 and in combination with itraconazole in Period 2. PK samples will be collected through out both study periods.Subjects will be confined in the clinic from check-in on Day -1 through the end-of study visit on Day 15.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Crossover Arm | Experimental | All patients will receive a single dose of surufatinib on day 1 in period 1, and a both itraconazole and single dose of surufatinib in period 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surufatinib | Drug | Surufatinib: 200 mg as single dose on Days 1 and 9 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUC (0-t) of Surufatinib | Pharmacokinetics of surufatinib by assessment of area under the plasma concentration time curve from zero to the last measurable concentration | Up to Day 15 |
| AUC of Surufatinib | Pharmacokinetics of surufatinib by assessment of area under the plasma concentration curve from zero extrapolated to infinity | Up to Day 15 |
| Cmax of Surufatinib | Pharmacokinetics of Surufatinib by assessment of maximum plasma Surufatinib concentration | Up to Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment emergent adverse events as assessed by CTCAE v5.0 | To evaluate the safety, in healthy subjects, of a single dose of surufatinib administered with and without food | Up to Day 15 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit | Dallas | Texas | 75247 | United States |
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| ID | Term |
|---|---|
| C000717729 | surufatinib |
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Itraconazole |
| Drug |
Itraconazole: 200 mg BID on Day 5, then 200 mg QD on Days 6 to 14 |
|
| D010879 |
| Piperazines |