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

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NCT02651623

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Study Location
Pfizer Clinical Research Unit
Brussels, , B-1070, Belgium
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study to Evaluate The Effect Of Sertraline on the Cardiac Repolarization in Healthy Subjects
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Sertraline
    Multiple doses of sertraline for 14 days
    Other Name: active drug
  • Drug: Moxifloxacin
    A single dose of 400 mg Moxifloxacin
    Other Name: Positive control
  • Drug: Drug - Placebo
    Placebo administered for 14 days
    Other Name: Placebo control
Study Arms  ICMJE
  • 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
    Intervention: Drug: Sertraline
  • Active Comparator: Moxifloxacin
    400 mg single dose of moxifloxacin (Avelox®) administered on Day 14
    Intervention: Drug: Moxifloxacin
  • Placebo Comparator: Drug - Placebo
    placebo - placebo administered on Days 1 through 14
    Intervention: Drug: Drug - Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 7, 2016)		54
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2016
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02651623
Other Study ID Numbers  ICMJE A0501104
2015-000103-47 ( EudraCT Number )
TQT ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP