Zoloft: Study to Evaluate The Effect Of Sertraline on the Cardiac Repolarization in Healthy Subjects
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
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 Comparator: Moxifloxacin 400 mg single dose of moxifloxacin (Avelox®) administered on Day 14 |
Drug: Moxifloxacin
A single dose of 400 mg Moxifloxacin
Other Names:
|
Placebo Comparator: Drug - Placebo placebo - placebo administered on Days 1 through 14 |
Drug: Drug - Placebo
Placebo administered for 14 days
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Postdose QTcF (Fridericia's correction) intervals [0 to 72 hours]
Secondary Outcome Measures
- 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]
Eligibility Criteria
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
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:
- To obtain contact information for a study center near you, click here.
- To obtain contact information for a study center near you, click here.
Publications
None provided.- A0501104
- 2015-000103-47
- TQT