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Trial record 12 of 331 for:    SERTRALINE

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

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ClinicalTrials.gov Identifier: NCT02651623
Recruitment Status : Completed
First Posted : January 11, 2016
Last Update Posted : October 12, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

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
Healthy Drug: Sertraline Drug: Moxifloxacin Drug: Drug - Placebo 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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
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 : January 2016
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Positive control

Placebo Comparator: Drug - Placebo
placebo - placebo administered on Days 1 through 14
Drug: Drug - Placebo
Placebo administered for 14 days
Other Name: Placebo control




Primary Outcome Measures :
  1. Postdose QTcF (Fridericia's correction) intervals [ Time Frame: 0 to 72 hours ]

Secondary Outcome Measures :
  1. Averse events, vital signs, physical examinations and abnormal laboratory for safety assessments (safety and tolerability) [ Time Frame: Through study completion, an average of 3 months ]
  2. Relationship between QTc prolongation and measured sertraline/metabolite plasma concentrations [ Time Frame: 0 to 72 hours ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02651623


Locations
Belgium
Pfizer Clinical Research Unit
Brussels, Belgium, B-1070
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02651623     History of Changes
Other Study ID Numbers: A0501104
2015-000103-47 ( EudraCT Number )
TQT ( Other Identifier: Alias Study Number )
First Posted: January 11, 2016    Key Record Dates
Last Update Posted: October 12, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Sertraline
Moxifloxacin
Fluoroquinolones
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Nucleic Acid Synthesis Inhibitors
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Neurotransmitter Agents
Serotonin Agents