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

Study Overview
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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

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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Sertraline
* Drug: Moxifloxacin
* Drug: Drug - Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sertraline<br>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<br>* Multiple doses of sertraline for 14 days<br>* Other names: active drug;|
| Active Comparator: Moxifloxacin<br>400 mg single dose of moxifloxacin (Avelox®) administered on Day 14 | Drug: Moxifloxacin<br>* A single dose of 400 mg Moxifloxacin<br>* Other names: Positive control;|
| Placebo Comparator: Drug - Placebo<br>placebo - placebo administered on Days 1 through 14 | Drug: Drug - Placebo<br>* Placebo administered for 14 days<br>* Other names: Placebo control;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |