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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Moxifloxacin; Other: Placebo; Drug: Quetiapine; Drug: Escitalopram

• Registration Number: NCT01871701
• Lead Sponsor: Seoul National University Hospital

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 Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-12-05
• Study First Submitted QC: 2013-06-04
• Study First Posted: 2013-06-07
• Status Verified: 2014-05
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Last Update Submitted: 2014-05-30
• Last Update Posted: 2014-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Moxifloxacin	Moxifloxacin	Moxifloxacin 400 mg (Avelox, Tablet)
Placebo	Placebo	Water intake
Quetiapine	Quetiapine	Quetiapine 100 mg (Seroquel, Tablet)
Escitalopram	Escitalopram	Escitalopram 20 mg (Lexapro, Tablet)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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, Cmax, Tmax, t1/2, CL/F
AUC (area under the plasma concentration-time curve)of quetiapine, moxifloxacin	Predose and 1, 2, 3, 4, 6, 8, 12, 16, 24 h postdose	AUC, Cmax, Tmax, t1/2, CL/F

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyounggi, Korea, Republic of