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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Placebo; Drug: Quetiapine; Drug: Moxifloxacin; Drug: Escitalopram

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 36 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Quetiapine; Quetiapine 100 mg (Seroquel, Tablet)	Drug: Quetiapine; Quetiapine; Other Names: Quetiapine 100 mg (Seroquel, Tablet)
Experimental: Moxifloxacin; Moxifloxacin 400 mg (Avelox, Tablet)	Drug: Moxifloxacin; Moxifloxacin; Other Names: Moxifloxacin 400 mg (Avelox, Tablet)
Experimental: Escitalopram; Escitalopram 20 mg (Lexapro, Tablet)	Drug: Escitalopram; Escitalopram; Other Names: Escitalopram 20 mg (Lexapro, Tablet)
Placebo Comparator: Placebo; Water intake	Other: Placebo; Placebo; Other Names: Water intake

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
AUC (area under the plasma concentration-time curve) of escitalopram	AUC, Cmax, Tmax, t1/2, CL/F	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	Predose and 1, 2, 3, 4, 6, 8, 12, 16, 24 h postdose

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Seoul National University Bundang Hospital
• Investigators: Principal Investigator: Jae-Yong Chung, MD, PhD, Department of Clinical Pharmacology and Therapeutics, Seoul National University Bundang Hospital, Seongnam, Korea

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: December 5, 2012
• First Submitted That Met QC Criteria: June 4, 2013
• First Posted (Estimate): June 7, 2013

Study Record Updates

• Last Update Posted (Estimate): June 3, 2014
• Last Update Submitted That Met QC Criteria: May 30, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Corrected QT interval prolongation; Psychotropic drugs
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Central Nervous System Depressants; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Antidepressive Agents, Second-Generation; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral, Combined; Contraceptives, Oral; Contraceptive Agents, Female; Antiparkinson Agents; Anti-Dyskinesia Agents; Citalopram; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; Quetiapine Fumarate; Dexetimide
• Other Study ID Numbers: CNSQT