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

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.54 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

SertralineDRUG

Multiple doses of sertraline for 14 days

MoxifloxacinDRUG

A single dose of 400 mg Moxifloxacin

Drug - PlaceboDRUG

Placebo administered for 14 days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Pfizer Clinical Research Unit

Brussels, Belgium

Outcomes

Primary Outcomes

Postdose QTcF (Fridericia's correction) intervals

Time frame: 0 to 72 hours

Secondary Outcomes

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

Relationship between QTc prolongation and measured sertraline/metabolite plasma concentrations

Time frame: 0 to 72 hours

Data from ClinicalTrials.gov

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