NCT02637193

A Study to Assess The Effects Of Effexor XR On Cardiac Repolarization In Healthy Adult Subjects

A Single Center, Three Period, Randomized, Three-way Crossover, Double-blind Placebo And Moxifloxacincontrolled Study To Assess The Effects Of Effexor Xr On Cardiac Repolarization In Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to demonstrate a lack of effect of venlafaxine (Effexor XR) on QTc intervals relative to time matched placebo in healthy volunteers

Detailed description

This is a single-center, randomized, double-blinded, placebo- and moxifloxacin-controlled, 3 period, 6-sequence, 3 treatment (venlafaxine and placebo blinded; moxifloxacin open label), 3-way crossover thorough QT (TQT) study of the effects of venlafaxine on cardiac repolarization in approximately 54 healthy subjects

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Venlafaxine	Multiple doses of Venlafaxine for 14 days plus 3 days of down titration
DRUG	Moxifloxacin	400 mg single dose moxifloxacin
DRUG	Drug - placebo	Placebo administered for 16 days

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2015-12-22
• Last updated: 2021-01-27

Locations

1 site across 1 country: United States