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Completed

NCT Number: NCT02651623

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

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

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Clinical Research Unit

Brussels, B-1070, Belgium

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion criteria

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).

Risk factors for QT prolongation or torsades de pointes

Treatment and study plan

Sertraline

Drug

Multiple doses of sertraline for 14 days

Other names: active drug

moxifloxacin

Drug

A single dose of 400 mg Moxifloxacin

Other names: Positive control

Drug - Placebo

Drug

Placebo administered for 14 days

Other names: Placebo control

Primary outcomes

  1. Postdose QTcF (Fridericia's correction) intervals

    Time frame: 0 to 72 hours

Secondary outcomes

  1. Averse events, vital signs, physical examinations and abnormal laboratory for safety assessments (safety and tolerability)

    Time frame: Through study completion, an average of 3 months

  2. Relationship between QTc prolongation and measured sertraline/metabolite plasma concentrations

    Time frame: 0 to 72 hours

Sponsors and collaborators

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Industry

Registry information

Official study title

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

Acronym: Zoloft

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 11, 2016
Registry last updated
Jan 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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