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

Seoul National University Hospital40 enrolled

Overview

To evaluate the corrected QT interval change(automatic-reading) after single oral administration of escitalopram, quetiapine and moxifloxacin versus placebo in healthy Korean Adults.

Randomized, Open-label, Placebo-controlled, 4-way crossover study

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

EscitalopramDRUG

Escitalopram

QuetiapineDRUG

Quetiapine

MoxifloxacinDRUG

Moxifloxacin

PlaceboOTHER

Eligibility

Sex: ALLMin age: 20 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Healthy subjects aged 20 - 40 years. 2. 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). 3. 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: 1. Presence or history of hypersensitivity or allergic reactions to drugs including investigational product (Escitalopram, Quetiapine, Moxifloxacin)) or other quinolone group antibiotics. 2. Subject judged not eligible for study participation by investigator.

Locations (1)

Seoul National University Bundang Hospital

Seongnam, Gyounggi, South Korea

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

AUC, Cmax, Tmax, t1/2, CL/F

Time frame: 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

Time frame: Predose and 1, 2, 3, 4, 6, 8, 12, 16, 24 h postdose

Data from ClinicalTrials.gov

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