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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-09-30

Brief Summary

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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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Detailed Description

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

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

Group Type EXPERIMENTAL

Sertraline

Intervention Type DRUG

Multiple doses of sertraline for 14 days

Moxifloxacin

400 mg single dose of moxifloxacin (Avelox®) administered on Day 14

Group Type ACTIVE_COMPARATOR

Moxifloxacin

Intervention Type DRUG

A single dose of 400 mg Moxifloxacin

Drug - Placebo

placebo - placebo administered on Days 1 through 14

Group Type PLACEBO_COMPARATOR

Drug - Placebo

Intervention Type DRUG

Placebo administered for 14 days

Interventions

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Sertraline

Multiple doses of sertraline for 14 days

Intervention Type DRUG

Moxifloxacin

A single dose of 400 mg Moxifloxacin

Intervention Type DRUG

Drug - Placebo

Placebo administered for 14 days

Intervention Type DRUG

Other Intervention Names

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active drug Positive control Placebo control

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes