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

January 25, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, B-1070
        • Pfizer Clinical Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Moxifloxacin
400 mg single dose of moxifloxacin (Avelox®) administered on Day 14
Drug: Moxifloxacin
A single dose of 400 mg Moxifloxacin
Other Names:
  • Positive control
Experimental: Sertraline
Maximum dose of 400 mg/day (200 mg BID given at approximately 12 hours apart) sertraline, dose titrated from a starting single dose (QD) of 50 mg in the morning on Day 1 followed by BID doses administered on Days 2 through 14 (Day 14 morning dose only) will be administered
Drug: Sertraline
Multiple doses of sertraline for 14 days
Other Names:
  • active drug
Placebo Comparator: Drug - Placebo
placebo - placebo administered on Days 1 through 14
Drug: Drug - Placebo
Placebo administered for 14 days
Other Names:
  • Placebo control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postdose QTcF (Fridericia's correction) intervals
Time Frame: 0 to 72 hours
0 to 72 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Through study completion, an average of 3 months
Relationship between QTc prolongation and measured sertraline/metabolite plasma concentrations
Time Frame: 0 to 72 hours
0 to 72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

November 20, 2015

First Submitted That Met QC Criteria

January 7, 2016

First Posted (Estimate)

January 11, 2016

Study Record Updates

Last Update Posted (Actual)

January 27, 2021

Last Update Submitted That Met QC Criteria

January 25, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A0501104
  • 2015-000103-47 (EudraCT Number)
  • TQT (Other Identifier: Alias Study Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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