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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Drug - Placebo; Drug: Moxifloxacin; Drug: Sertraline

• Registration Number: NCT02651623
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief 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

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 Timeline

• Study First Submitted: 2015-11-20
• Study Start: 2016-01
• Study First Submitted QC: 2016-01-07
• Study First Posted: 2016-01-11
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-25
• Last Update Posted: 2021-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Drug - Placebo	Drug - Placebo	placebo - placebo administered on Days 1 through 14
Moxifloxacin	Moxifloxacin	400 mg single dose of moxifloxacin (Avelox®) administered on Day 14
Sertraline	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

Primary Outcome Measures

Name	Time	Method
Postdose QTcF (Fridericia's correction) intervals	0 to 72 hours

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Clinical Research Unit; 🇧🇪 Brussels, Belgium