Clinical Trial to Investigate the Effect on Corrected QT... | NCT01871701

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

NCT01871701

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Jun 3, 2014Estimated

Enrollment

40Actual

Phase

Phase 1

Conditions

Healthy

Interventions

Escitalopram
Quetiapine
Moxifloxacin
Placebo

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2012

Primary Completion Date

May 2014Actual

Completion Date

May 2014Actual

First Submitted Date

Dec 5, 2012

First Submission Date that Met QC Criteria

Jun 4, 2013

First Posted Date

Jun 7, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 30, 2014

Last Update Posted Date

Jun 3, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jae Yong Chung, Assistant Professor, Seoul National University Bundang HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Name	Class
Seoul National University Bundang Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Quetiapine	Experimental	Quetiapine 100 mg (Seroquel, Tablet)	Drug: Quetiapine
Moxifloxacin	Experimental	Moxifloxacin 400 mg (Avelox, Tablet)	Drug: Moxifloxacin
Escitalopram	Experimental	Escitalopram 20 mg (Lexapro, Tablet)	Drug: Escitalopram
Placebo	Placebo Comparator	Water intake	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Escitalopram	Drug	Escitalopram	Escitalopram	Escitalopram 20 mg (Lexapro, Tablet)

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jae-Yong Chung, MD, PhD	Department of Clinical Pharmacology and Therapeutics, Seoul National University Bundang Hospital, Seongnam, Korea	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital		Seongnam	Gyounggi		South Korea

Intervention Browse Module

MeSH Terms

ID	Term
D000089983	Escitalopram
D013607	Tablets
D000069348	Quetiapine Fumarate
D000077266	Moxifloxacin
D004326	Drinking

Ancestor Terms

ID	Term
D011437	Propylamines
D000588	Amines
D009930	Organic Chemicals
D009570	Nitriles
D001572

Browse Leaves

Not provided

Browse Branches

Not provided