NCT01525394

A Double-Blind Study in Healthy Volunteers to Assess the Effect of E7080 on the QTc Interval

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Refractory Solid Tumors
• Lymphomas

Interventions

Type	Name	Description
DRUG	Lenvatinib	32 mg will be administered orally as three 4 mg and two 10 mg capsules as a single dose.
DRUG	Moxifloxacin 400 mg	Moxifloxacin 400 mg will be administered orally as one 400 mg tablet.
DRUG	Placebos (matched to 4 mg and 10 mg lenvatinib capsules).	The Placebo dose will consist of three 4 mg and two 10 mg placebo capsules.

Timeline

• Start date: 2010-12-01
• Primary completion: 2011-08-01
• First posted: 2012-02-02
• Last updated: 2023-06-22

Locations

1 site across 1 country: United States