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Completed

NCT Number: NCT01871701

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

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

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Key information

Conditions

Healthy

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Bundang Hospital

Seongnam, Gyounggi, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Escitalopram

Drug

Escitalopram

Other names: Escitalopram 20 mg (Lexapro, Tablet)

Quetiapine

Drug

Quetiapine

Other names: Quetiapine 100 mg (Seroquel, Tablet)

moxifloxacin

Drug

Moxifloxacin

Other names: Moxifloxacin 400 mg (Avelox, Tablet)

Placebo

Other

Placebo

Other names: Water intake

Primary outcomes

  1. 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

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

    Time frame: Predose and 1, 2, 3, 4, 6, 8, 12, 16, 24, 30, 36, 48h postdose

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

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

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

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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Seoul National University Bundang Hospital

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 7, 2013
Registry last updated
Jun 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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