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Phase 1 Study to Assess the Effects of EVP-6124 on the QT/QTc Interval in Healthy Subjects

NCT01487135 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2014-10-10

No results posted yet for this study

Summary

The purpose of this study is to evaluate the effect of EVP-6124 at therapeutic and supratherapeutic concentrations on cardiac repolarization in healthy subjects.

Conditions

  • Healthy Subjects
  • Cardiac Repolarization

Interventions

DRUG

EVP-6124

A single oral low dose of EVP-6124 in cranberry juice (180 mL) administered on Day 1 and a high dose of EVP-6124 in cranberry juice (180 mL) administered on Day 2.

DRUG

Placebo

Cranberry juice only (180 mL) administered orally on both Day 1 and Day 2.

DRUG

Moxifloxacin

A moxifloxacin 400 mg tablet administered orally on Day 1

Sponsors & Collaborators

  • Quintiles, Inc.

    collaborator INDUSTRY

  • FORUM Pharmaceuticals Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2013-09-30
Completion
2013-09-30

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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 NCT01487135 on ClinicalTrials.gov