NCT01240408

E7080 Food Effect Study in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	HOPE	10 mg lenvatinib (1x10 mg lenvatinib capsule) with food
DRUG	HOPE	10 mg lenvatinib (1x10 mg lenvatinib capsule) without food

Timeline

• Start date: 2010-07-01
• Primary completion: 2011-11-01
• First posted: 2010-11-15
• Last updated: 2015-03-04

Locations

1 site across 1 country: United States