Clinical Trial to Investigate the Effect on Corrected QT Interval Prolongation by Psychotropic Drugs

Study Overview
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Brief Summary
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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
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Randomized, Open-label, Placebo-controlled, 4-way crossover study

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Escitalopram
* Drug: Quetiapine
* Drug: Moxifloxacin
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Quetiapine<br>Quetiapine 100 mg (Seroquel, Tablet) | Drug: Quetiapine<br>* Quetiapine<br>* Other names: Quetiapine 100 mg (Seroquel, Tablet);|
| Experimental: Moxifloxacin<br>Moxifloxacin 400 mg (Avelox, Tablet) | Drug: Moxifloxacin<br>* Moxifloxacin<br>* Other names: Moxifloxacin 400 mg (Avelox, Tablet);|
| Experimental: Escitalopram<br>Escitalopram 20 mg (Lexapro, Tablet) | Drug: Escitalopram<br>* Escitalopram<br>* Other names: Escitalopram 20 mg (Lexapro, Tablet);|
| Placebo Comparator: Placebo<br>Water intake | Other: Placebo<br>* Placebo<br>* Other names: Water intake;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corrected QT interval prolongation |  | Predose (3 times) and 1, 2, 3, 4, 6, 8, 12, 16, 24 h, additional 26, 28, 32, 48 h after escitalopram dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC (area under the plasma concentration-time curve) of escitalopram | AUC, Cmax, Tmax, t1/2, CL/F | 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 | AUC, Cmax, Tmax, t1/2, CL/F | Predose and 1, 2, 3, 4, 6, 8, 12, 16, 24 h postdose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Corrected QT interval prolongation, Psychotropic drugs