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A Study to Evaluate the Effects of E2609 on QTc Interval in Healthy Subjects

NCT02222324 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-11-03

No results posted yet for this study

Summary

This thorough QT (TQT) study will take place in healthy subjects administered single doses of study drug. It will be a randomized, double-blind, placebo and active-controlled, 4-treatment crossover study. Subjects will be randomized in an equal ratio to one of 12 possible treatment sequences. Each treatment sequence will comprise all 4 treatments.

Conditions

  • Healthy Subjects

Interventions

DRUG

Placebo

8 placebo tablets matching E2609

DRUG

E2609

E2609 will be administered as 8 tablets

DRUG

Moxifloxacin

Administered as 1 tablet with 7 tablets of placebo matching E2609

Sponsors & Collaborators

  • Eisai Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2014-10-31
Completion
2014-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT02222324 on ClinicalTrials.gov