Phase 1 Study to Assess the Effects of EVP-6124 on the QT/QTc Interval in Healthy Subjects (TQT)
|ClinicalTrials.gov Identifier: NCT01487135|
Recruitment Status : Completed
First Posted : December 7, 2011
Last Update Posted : October 10, 2014
|Condition or disease||Intervention/treatment||Phase|
|Healthy Subjects Cardiac Repolarization||Drug: EVP-6124 Drug: Placebo Drug: Moxifloxacin||Phase 1|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|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.|
|Study Start Date :||December 2011|
|Primary Completion Date :||September 2013|
|Study Completion Date :||September 2013|
A single low dose of 8-mg EVP-6124 and A single high dose of 80-mg EVP-6124
Cranberry juice only (180 mL) administered orally on both Day 1 and Day 2.
Placebo Comparator: Placebo
Cranberry juice (180 mL)
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.
Active Comparator: Moxifloxacin
A single dose of 400-mg Moxifloxacin
A moxifloxacin 400 mg tablet administered orally on Day 1
Other Name: Avelox
- Change-from-baseline in individual corrected QTc (ΔQTcI) for EVP-6124 vs. placebo [ Time Frame: Day 1: predose to 20 hours postdose; Day 2 predose to 168 hours postdose ]
Change-from-baseline in Fridericia's correction QTc (ΔQTcF) and change-from-baseline in Bazett's correction QTc (ΔQTcB) will be secondary variables.
The placebo-corrected baseline-adjusted QTc (ΔΔQTc), calculated as differences between time-matched mean change-from-baseline QTc values obtained on Day 1 (low dose) and on Day 2 (high dose) of the EVP-6124 treatment relative to the corresponding QTc values obtained on Day 1 and Day 2 of the placebo treatment, will be evaluated to quantify the effect of EVP-6124 on cardiac repolarization.
- Change-from-baseline in individual corrected QTc (ΔQTcI) for positive control vs. placebo [ Time Frame: Day 1: predose to 20 hours postdose ]The placebo-corrected baseline-adjusted QTc (ΔΔQTc), calculated as differences between time-matched mean change-from-baseline QTc values obtained on Day 1 of the moxifloxacin treatment relative to QTc values obtained on Day 1 of the placebo treatment, will be evaluated to establish assay sensitivity.
- Safety and tolerability of EVP-6124 at low dose and high doses [ Time Frame: Day -1 through follow-up (5 to 10 days after discharge) ]All AEs (adverse experiences) spontaneously reported by subjects and/or observed by investigator and evaluation of physical examinations, prior and concomitant medications, clinical laboratory tests, ECGs, and vital signs measurements.