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

Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02651623
Collaborator
(none)
54
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Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
54 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Other
Official Title:
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
Study Start Date :
Jan 1, 2016
Actual Primary Completion Date :
Sep 1, 2016
Actual Study Completion Date :
Sep 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

Drug: Sertraline
Multiple doses of sertraline for 14 days
Other Names:
  • active drug
  • Active Comparator: Moxifloxacin

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

    Drug: Moxifloxacin
    A single dose of 400 mg Moxifloxacin
    Other Names:
  • Positive control
  • Placebo Comparator: Drug - Placebo

    placebo - placebo administered on Days 1 through 14

    Drug: Drug - Placebo
    Placebo administered for 14 days
    Other Names:
  • Placebo control
  • Outcome Measures

    Primary Outcome Measures

    1. Postdose QTcF (Fridericia's correction) intervals [0 to 72 hours]

    Secondary Outcome Measures

    1. Averse events, vital signs, physical examinations and abnormal laboratory for safety assessments (safety and tolerability) [Through study completion, an average of 3 months]

    2. Relationship between QTc prolongation and measured sertraline/metabolite plasma concentrations [0 to 72 hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pfizer Clinical Research Unit Brussels Belgium B-1070

    Sponsors and Collaborators

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

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
    ClinicalTrials.gov Identifier:
    NCT02651623
    Other Study ID Numbers:
    • A0501104
    • 2015-000103-47
    • TQT
    First Posted:
    Jan 11, 2016
    Last Update Posted:
    Jan 27, 2021
    Last Verified:
    Jan 1, 2021
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 27, 2021