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This is a double-blind (vis-a-vis lenvatinib), randomized, placebo-controlled, three-treatment, three-way crossover study in healthy subjects. There are two phases in this study: Pre-Randomization and Randomization. The Pre-Randomization Phase consists of Screening and Baseline Period 1. The Randomization Phase consists of five periods: Treatment Period 1, Baseline Period 2, Treatment Period 2, Baseline Period 3, and Treatment Period 3. Completion of study termination procedures will be performed at Visit 11.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lenvatinib Capsules | Experimental |
| |
| Moxifloxacin tablets | Active Comparator |
| |
| Placebos | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lenvatinib | Drug | 32 mg will be administered orally as three 4 mg and two 10 mg capsules as a single dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the potential for QT/QTc prolongation by 32 mg lenvatinib using a placebo control and moxifloxacin as the positive control. | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety of lenvatinib in healthy subjects. | 2 months |
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Inclusion Criteria:
Subjects must meet all of the following criteria to be included in this study:
Exclusion Criteria:
Subjects who meet any of the following criteria will be excluded from participation in the study:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Shumaker | Eisai Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charles River | Tacoma | Washington | 98418 | United States |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| C531958 | lenvatinib |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Moxifloxacin 400 mg | Drug | Moxifloxacin 400 mg will be administered orally as one 400 mg tablet. |
|
| Placebos (matched to 4 mg and 10 mg lenvatinib capsules). | Drug | The Placebo dose will consist of three 4 mg and two 10 mg placebo capsules. |
|
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |