drugset / Trial / NCT01525394

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

NCT01525394

Phase 1 Completed 52 enrolled Eisai Inc.
RandomizedCrossoverTriple-blindBasic science

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.

Timeline

Start
2010-12
Primary completion
2011-08
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Lenvatinib Small molecule 32 mg Oral
Comparator Moxifloxacin Small molecule 400 mg Oral