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

Viatris

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Sertraline

Drug: Moxifloxacin

Drug: Drug - Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02651623

2015-000103-47 (EudraCT Number)

TQT (Other Identifier)

A0501104

Details and patient eligibility

About

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

Full description

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

Enrollment

54 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

54 participants in 3 patient groups, including a placebo group

Sertraline

Experimental group

Description:

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

Treatment:

Drug: Sertraline

Moxifloxacin

Active Comparator group

Description:

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

Treatment:

Drug: Moxifloxacin

Drug - Placebo

Placebo Comparator group

Description:

placebo - placebo administered on Days 1 through 14