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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02651623

Acronym

Zoloft

Enrollment

Registered

2016-01-11

Start date

2016-01-31

Completion date

2016-09-30

Last updated

2021-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief 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.

Interventions

DRUGSertraline

Multiple doses of sertraline for 14 days

DRUGMoxifloxacin

A single dose of 400 mg Moxifloxacin

DRUGDrug - Placebo

Placebo administered for 14 days

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Postdose QTcF (Fridericia's correction) intervals	0 to 72 hours

Secondary

Measure	Time frame
Averse events, vital signs, physical examinations and abnormal laboratory for safety assessments (safety and tolerability)	Through study completion, an average of 3 months
Relationship between QTc prolongation and measured sertraline/metabolite plasma concentrations	0 to 72 hours

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026