MedTrace Logo

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

NCT01525394 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2023-06-22

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Eisai Inc.

    lead INDUSTRY

Principal Investigators

  • Robert Shumaker · Eisai Inc.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2011-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01525394 on ClinicalTrials.gov