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An Open-label, Randomized, Three-period, Crossover Study of the Effect of Food on the Pharmacokinetics of a Single Oral Dose of Sitravatinib in Healthy Adult Subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fasted dosing followed by fed dosing (high-fat meal) followed by fed dosing (low-fat meal) | Experimental | Dosing in the fasted state followed by fed dosing after high and low fat meals |
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| Fasted dosing followed by fed dosing (low-fat meal) followed by fed dosing (high-fat meal) | Experimental | Dosing in the fasted state followed by fed dosing after low and high fat meals |
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| Fed dosing (high-fat meal) followed by fasted dosing followed by fed dosing (low-fat meal) | Experimental | Dosing after a high-fat meal followed by doing in the fasted sate followed by dosing after a low-fat meal |
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| Fed dosing (high-fat) followed by fed dosing (low-fat) followed by dosing in the fasted state | Experimental | Fed dosing (high-fate meal) followed by fed dosing (low-fate meal) followed by dosing in the fasted state |
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| Fed dosing (low-fat) followed dosing in the fasted state followed by fed dosing (high fat) | Experimental | Fed dosing (low-fat) meal followed dosing in the fasted state followed by fed dosing (high-fat meal) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sitravatinib | Drug | 100 mg sitravatinib on Day 1 of each of 3 periods |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics - Cmax (sitravatinib) | Maximum observed plasma concentration | Up to 72 hours after dosing |
| Pharmacokinetics - AUC∞ (sitravatinib) | Area under the plasma concentration-time curve from time zero extrapolated to infinity | Up to 72 hours after dosing |
| Pharmacokinetics - AUClast (sitravatinib) | AUC from time zero to the last measured time point | Up to 72 hours after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (AEs) | Incidence and severity of adverse events (AEs) dosed in the fasted and fed states in healthy adult subjects | Up to 44 days |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Curtis Chin, MD | Mirati Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit, Inc. | Dallas | Texas | 75247 | United States |
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| ID | Term |
|---|---|
| C000611865 | sitravatinib |
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Three Period Crossover
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| Fed dosing (low-fat) followed by fed dosing (high-fat) followed by dosing in the fasted state | Experimental | Fed dosing after a low-fat and high-fate meals followed by dosing in the fasted state |
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