NCT01871701CompletedPhase 1
Clinical Trial to Investigate the Effect on Corrected QT Interval Prolongation by Psychotropic Drugs in Healthy Korean Adults After a Single Oral Administration of Escitalopram, Quetiapine, and Moxifloxacin
Seoul National University Hospital1 site in 1 country40 target enrollmentStarted: November 2012Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Corrected QT interval prolongation
Study Overview
Brief Summary
To evaluate the corrected QT interval change(automatic-reading) after single oral administration of escitalopram, quetiapine and moxifloxacin versus placebo in healthy Korean Adults.
Detailed Description
Randomized, Open-label, Placebo-controlled, 4-way crossover study
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy subjects aged 20 - 40 years.
- •A body weight in the range of 50 kg (inclusive) - 90 kg (inclusive) and a body mass index (BMI) in the range 19.0 kg/m2 (inclusive) - 25.0 kg/m2 (inclusive).
- •Sufficient ability to understand the nature of the study and any hazards of participating in it. Provide written informed consent after being fully. informed about the study procedures.
Exclusion Criteria
- •Presence or history of hypersensitivity or allergic reactions to drugs including investigational product (Escitalopram, Quetiapine, Moxifloxacin)) or other quinolone group antibiotics.
- •Subject judged not eligible for study participation by investigator.
Arms & Interventions
Quetiapine
Experimental
Quetiapine 100 mg (Seroquel, Tablet)
Intervention: Quetiapine (Drug)
Moxifloxacin
Experimental
Moxifloxacin 400 mg (Avelox, Tablet)
Intervention: Moxifloxacin (Drug)
Escitalopram
Experimental
Escitalopram 20 mg (Lexapro, Tablet)
Intervention: Escitalopram (Drug)
Placebo
Placebo Comparator
Water intake
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Corrected QT interval prolongation
Time Frame: Predose (3 times) and 1, 2, 3, 4, 6, 8, 12, 16, 24 h, additional 26, 28, 32, 48 h after escitalopram dosing
Secondary Outcomes
- AUC (area under the plasma concentration-time curve) of escitalopram(Predose and 1, 2, 3, 4, 6, 8, 12, 16, 24, 30, 36, 48h postdose)
- AUC (area under the plasma concentration-time curve)of quetiapine, moxifloxacin(Predose and 1, 2, 3, 4, 6, 8, 12, 16, 24 h postdose)
Investigators
Jae Yong Chung
Assistant Professor
Seoul National University Bundang Hospital
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 1
A Study of QT and QTc Intervals in Patients Administered Extended Release Paliperidone or QuetiapineSchizophreniaSchizoaffective DisorderNCT00791622Johnson & Johnson Pharmaceutical Research & Development, L.L.C.110
Completed
Phase 1
Study to Evaluate the QT / QTc Interval Prolongation Potential of VericiguatCoronary Artery DiseaseNCT03504982Bayer74
Completed
Phase 1
A Study to Evaluate the Effect of JNJ-53718678 on the Cardiac Repolarization Interval in Healthy Adult ParticipantsHealthyNCT03696459Janssen Research & Development, LLC52
Completed
Phase 1
Study To Evaluate The Effect Of A Multiple Oral Dose Of PF-00232798 On QT Intervals In Healthy SubjectsHealthyNCT01140425Pfizer44
Completed
Phase 1
A Thorough QT Study of Aticaprant (JNJ-67953964) in Healthy Adult ParticipantsHealthyNCT05387759Janssen Research & Development, LLC60