NCT02651623

Study to Evaluate The Effect Of Sertraline on the Cardiac Repolarization in Healthy Subjects

A Phase 1, Single Center Randomized, Three-way Crossover, Double-blinded, Placebo- And Moxifloxacin-controlled Thorough Qt (Tqt) Study To Determine The Effects Of Sertraline (Zoloft (Registered)) On The Cardiac Repolarization In Healthy 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 sertraline on QTc intervals relative to time-matched placebo in healthy subjects

Detailed description

Evaluate multiple doses of 400 mg per day of sertraline on QTc, and evaluate the safety and tolerability of sertraline in healthy subjects.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Sertraline	Multiple doses of sertraline for 14 days
DRUG	Moxifloxacin	A single dose of 400 mg Moxifloxacin
DRUG	Drug - Placebo	Placebo administered for 14 days

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2016-01-11
• Last updated: 2021-01-27

Locations

1 site across 1 country: Belgium