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NCT02651623 Clinical Trial

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

Healthy Clinical Trial

— Zoloft  

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02651623
Other study ID # A0501104
Secondary ID 2015-000103-47TQ
Status Completed
Phase Phase 1
First received
Last updated
Start date January 2016
Est. completion date September 2016

Study information
Verified date January 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 54
Est. completion date September 2016
Est. primary completion date September 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Sertraline
Multiple doses of sertraline for 14 days
• Moxifloxacin
A single dose of 400 mg Moxifloxacin
• Drug - Placebo
Placebo administered for 14 days

Locations
Country Name City State
Belgium Pfizer Clinical Research Unit Brussels

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Postdose QTcF (Fridericia's correction) intervals 0 to 72 hours
Secondary Averse events, vital signs, physical examinations and abnormal laboratory for safety assessments (safety and tolerability) Through study completion, an average of 3 months
Secondary Relationship between QTc prolongation and measured sertraline/metabolite plasma concentrations 0 to 72 hours
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