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

NCT02651623 | Completed Phase 1

• 3 other identifiers: A05011042015-000103-47TQT
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Postdose QTcF (Fridericia's correction) intervals

  0 to 72 hours

Secondary Outcomes (2)

• Averse events, vital signs, physical examinations and abnormal laboratory for safety assessments (safety and tolerability)

  Through study completion, an average of 3 months

• Relationship between QTc prolongation and measured sertraline/metabolite plasma concentrations

  0 to 72 hours

Study Arms (3)

Sertraline

EXPERIMENTAL

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

Moxifloxacin

ACTIVE COMPARATOR

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

Drug: Moxifloxacin

Drug - Placebo

PLACEBO COMPARATOR

placebo - placebo administered on Days 1 through 14

Drug: Drug - Placebo

Interventions

Sertraline DRUG

Multiple doses of sertraline for 14 days

Also known as: active drug

Sertraline

Moxifloxacin DRUG

A single dose of 400 mg Moxifloxacin

Also known as: Positive control

Moxifloxacin

Drug - Placebo DRUG

Placebo administered for 14 days

Also known as: Placebo control

Drug - Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Pfizer Clinical Research Unit

Brussels, B-1070, Belgium

Location

Related Links

• To obtain contact information for a study center near you, click here.
• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Sertraline; Bulk Drugs; Moxifloxacin

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Pharmaceutical Preparations; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2015
• First Posted: January 11, 2016
• Study Start: January 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: January 27, 2021

Record last verified: 2021-01

Locations

BE (1)