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This study will be a 2-period study conducted with 26 healthy male or female subjects. Subjects will be randomly assigned to either receive a single dose of surufatinib with food in period 1, then without food in period 2, or vice-versa.
This study will be a single center, open label, randomized crossover, 2-period study conducted with 26 healthy male or female subjects. Subjects will be randomly assigned to 1 of the 2 possible treatment sequences as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fed/Fasted | Experimental | surufatinib with food on Day 1 and surufatinib without food on Day 8 |
|
| Fasted/Fed | Experimental | surufatinib without food on Day 1 and surufatinib with food on Day 8 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| surufatinib | Drug | Surufatinib: 300 mg as a single dose on Days 1 and 8 with or without food |
|
| 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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| Name | Affiliation | Role |
|---|---|---|
| Jeanelle Kam, MD | Covance Clinical Research Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit | Dallas | Texas | 75247 | United States |
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| ID | Term |
|---|---|
| C000717729 | surufatinib |
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Subjects will be randomly assigned to 1 of the 2 possible treatment sequences as follows:
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