Clinical Trial to Investigate the Effect on Corrected QT Interval Prolongation by Psychotropic Drugs
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Nov 2012
Longer than P75 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 5, 2012
CompletedFirst Posted
Study publicly available on registry
June 7, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedJune 3, 2014
May 1, 2014
1.5 years
December 5, 2012
May 30, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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 (area under the plasma concentration-time curve)of quetiapine, moxifloxacin
Predose and 1, 2, 3, 4, 6, 8, 12, 16, 24 h postdose
Study Arms (4)
Quetiapine
EXPERIMENTALQuetiapine 100 mg (Seroquel, Tablet)
Moxifloxacin
EXPERIMENTALMoxifloxacin 400 mg (Avelox, Tablet)
Escitalopram
EXPERIMENTALEscitalopram 20 mg (Lexapro, Tablet)
Placebo
PLACEBO COMPARATORWater intake
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Bundang Hospital
Seongnam, Gyounggi, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jae-Yong Chung, MD, PhD
Department of Clinical Pharmacology and Therapeutics, Seoul National University Bundang Hospital, Seongnam, Korea
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
December 5, 2012
First Posted
June 7, 2013
Study Start
November 1, 2012
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
June 3, 2014
Record last verified: 2014-05