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Spots Global Cancer Trial Database for E7080 Food Effect Study in Healthy Subjects

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Trial Identification

Brief Title: E7080 Food Effect Study in Healthy Subjects

Official Title: E7080 Food Effect Study in Healthy Subjects

Study ID: NCT01240408

Conditions

Cancer

Interventions

HOPE
HOPE

Study Description

Brief Summary: 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.

Detailed Description:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT

Sex: ALL

Healthy Volunteers: Yes

Locations

Charles River Clinical Studies, NW, Tacoma, Washington, United States

Contact Details

Name: Study Director

Affiliation: Eisai Inc.

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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