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This will be a randomized, single-dose, open-label, two-period crossover study in 16 healthy subjects. The study will consist of two phases: Pre-randomization and Randomization. The Pre-randomization phase will have two periods: Screening and Baseline. In the Randomization Phase, subjects will be randomized to one of two possible treatment sequences (fed/fasted and fasted/fed). In each period, subjects will receive a single capsule containing 10 mg lenvatinib either with or without a standard breakfast. There will be a 2-week washout between treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group 1 | Experimental | 10 mg lenvatinib (1x10 mg lenvatinib capsule) with food |
|
| Treatment group 2 | Experimental | 10 mg lenvatinib (1x10 mg lenvatinib capsule) without food |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HOPE | Drug | 10 mg lenvatinib (1x10 mg lenvatinib capsule) with food |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine the effect of food on the bioavailability of lenvatinib. | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Eisai Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charles River Clinical Studies, NW | Tacoma | Washington | 98418 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C531958 | lenvatinib |
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| HOPE | Drug | 10 mg lenvatinib (1x10 mg lenvatinib capsule) without food |
|
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