Healthy Subjects Clinical Trial
Official title:
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.
The purpose of this study is to evaluate the effect of EVP-6124 at therapeutic and supratherapeutic concentrations on cardiac repolarization in healthy subjects.
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).
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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