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

Last updated on May 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Clinical Research Unit
Brussels, , B-1070 Belgium
Contact
1-800-718-1021
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

NCT02651623
Pfizer
Completed
Study to Evaluate The Effect Of Sertraline on the Cardiac Repolarization in Healthy Subjects

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Study to Evaluate The Effect Of Sertraline on the Cardiac Repolarization in Healthy Subjects
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
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
Evaluate multiple doses of 400 mg per day of sertraline on QTc, and evaluate the safety and tolerability of sertraline in healthy subjects.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Healthy
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
September 2016
September 2016   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT02651623
A0501104
2015-000103-47 ( EudraCT Number )
TQT ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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