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

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ClinicalTrials.gov Identifier: NCT01871701
Recruitment Status : Completed
First Posted : June 7, 2013
Last Update Posted : June 3, 2014
Sponsor:
Collaborator:
Seoul National University Bundang Hospital
Information provided by (Responsible Party):
Jae Yong Chung, Seoul National University Bundang 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Escitalopram Drug: Quetiapine Drug: Moxifloxacin Other: Placebo Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014


Arm Intervention/treatment
Experimental: Quetiapine
Quetiapine 100 mg (Seroquel, Tablet)
Drug: Quetiapine
Quetiapine
Other Name: Quetiapine 100 mg (Seroquel, Tablet)

Experimental: Moxifloxacin
Moxifloxacin 400 mg (Avelox, Tablet)
Drug: Moxifloxacin
Moxifloxacin
Other Name: Moxifloxacin 400 mg (Avelox, Tablet)

Experimental: Escitalopram
Escitalopram 20 mg (Lexapro, Tablet)
Drug: Escitalopram
Escitalopram
Other Name: Escitalopram 20 mg (Lexapro, Tablet)

Placebo Comparator: Placebo
Water intake
Other: Placebo
Placebo
Other Name: Water intake




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01871701


Locations
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Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Gyounggi, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Seoul National University Bundang Hospital
Investigators
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Principal Investigator: Jae-Yong Chung, MD, PhD Department of Clinical Pharmacology and Therapeutics, Seoul National University Bundang Hospital, Seongnam, Korea
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Responsible Party: Jae Yong Chung, Assistant Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01871701    
Other Study ID Numbers: CNSQT
First Posted: June 7, 2013    Key Record Dates
Last Update Posted: June 3, 2014
Last Verified: May 2014
Keywords provided by Jae Yong Chung, Seoul National University Bundang Hospital:
Corrected QT interval prolongation
Psychotropic drugs
Additional relevant MeSH terms:
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Moxifloxacin
Dexetimide
Quetiapine Fumarate
Citalopram
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptive Agents, Hormonal
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Neurotransmitter Agents
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics