NCT01487135

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

A Randomized, Double-blind, Placebo- and Active-controlled, 3-way Crossover, Phase 1 Study to Evaluate the Effect of EVP-6124 at Therapeutic and Supratherapeutic Concentrations Following a 2-dose EVP-6124 Regimen on the QT Interval in Healthy Male and Female Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: FORUM Pharmaceuticals Inc · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

Subjects will be randomized to six treatment sequences of 10 subjects each. Subjects will be admitted to the clinic on Day -1 before dosing. Each of the EVP-6124 and placebo treatment periods (blinded) will include a 10-day/9-night confinement to the Clinical Pharmacology Unit (CPU) with study drugs being administered on Day 1 and Day 2. The moxifloxacin treatment period (open-label) will include a 3-day/2-night confinement to the CPU with moxifloxacin administration on Day 1. The study will include 2 washout periods in which each washout starts from the time of the last dose of the preceding treatment period to the first dose of the next treatment period. The washouts following the EVP-6124 or placebo treatments will be 30 days while the washout following the moxifloxacin treatment will be 7 days. Follow-up visit (5 to 10 days following discharge from the CPU).

Conditions

• Healthy Subjects
• Cardiac Repolarization

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-12-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2011-12-07
• Last updated: 2014-10-10