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

Condition(s) targeted: Healthy

Intervention: Escitalopram (Drug); Quetiapine (Drug); Moxifloxacin (Drug); Placebo (Other)

Phase: Phase 1

Status: Completed

Sponsored by: Seoul National University Hospital

Official(s) and/or principal investigator(s):
Jae-Yong Chung, MD, PhD, Principal Investigator, Affiliation: Department of Clinical Pharmacology and Therapeutics, Seoul National University Bundang Hospital, Seongnam, Korea

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

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Corrected QT interval prolongation

Secondary outcome:

AUC (area under the plasma concentration-time curve) of escitalopram

AUC (area under the plasma concentration-time curve)of quetiapine, moxifloxacin

Detailed description: Randomized, Open-label, Placebo-controlled, 4-way crossover study

Minimum age: 20 Years. Maximum age: 40 Years. Gender(s): Both.

Criteria:

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.

Seoul National University Bundang Hospital, Seongnam, Gyounggi, Korea, Republic of

Starting date: November 2012
Last updated: May 30, 2014