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Study Of The Effects Of SB 480848 (Darapladib) On The Electrical Conduction Of The Heart

Primary Purpose

Atherosclerosis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Darapladib

About this trial

This is an interventional treatment trial for Atherosclerosis focused on measuring darapladib, moxifloxacin, QT study

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy
Body weight greater than 50 kg (110 lbs) and a body mass index between 19 and 30
Signed and dated written informed consent prior to admission to the study
Subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions

Exclusion Criteria:

cardiac abnormalities
history of asthma or severe allergic reactions
history of alcohol or drug abuse
use of prescription or non-prescription drugs or vitamins or herbal supplements
history of cholecystectomy or biliary tract disease
pregnant or nursing women
history of allergy to the study drugs

Sites / Locations

GSK Investigational Site

Outcomes

Primary Outcome Measures

Change in QTc interval as compared to placebo and moxifloxacin

Secondary Outcome Measures

Change in ECG parameters as compared to placebo and moxifloxacin

Full Information

NCT ID

NCT00411073

First Posted

December 12, 2006

Last Updated

October 27, 2016

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00411073

Brief Title

Study Of The Effects Of SB 480848 (Darapladib) On The Electrical Conduction Of The Heart

Official Title

A Study to Evaluate the Effect of Repeat Oral Doses of Darapladib on Cardiac Conduction as Compared to Placebo and a Single Oral Dose of Moxifloxacin

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

December 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This is a study to assess the effects of darapladib on the cardiac conduction of the heart as compared to placebo and moxifloxacin. This a four period crossover design with each period lasting about 10 days. There will be a 7 to 10 day wash out in between each period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atherosclerosis

Keywords

darapladib, moxifloxacin, QT study

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

Double

Allocation

Randomized

Enrollment

72 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Darapladib

Primary Outcome Measure Information:

Title

Change in QTc interval as compared to placebo and moxifloxacin

Time Frame

throughout the study

Secondary Outcome Measure Information:

Title

Change in ECG parameters as compared to placebo and moxifloxacin

Time Frame

throughout the study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy Body weight greater than 50 kg (110 lbs) and a body mass index between 19 and 30 Signed and dated written informed consent prior to admission to the study Subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions Exclusion Criteria: cardiac abnormalities history of asthma or severe allergic reactions history of alcohol or drug abuse use of prescription or non-prescription drugs or vitamins or herbal supplements history of cholecystectomy or biliary tract disease pregnant or nursing women history of allergy to the study drugs

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Evansville

State/Province

Indiana

ZIP/Postal Code

47714

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Links:

URL

https://www.clinicalstudydatarequest.com

Description

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Available IPD and Supporting Information:

Available IPD/Information Type

Statistical Analysis Plan

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

SB 480848/035

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Clinical Study Report

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

SB 480848/035

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Individual Participant Data Set

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

SB 480848/035

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Annotated Case Report Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

SB 480848/035

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Study Protocol

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

SB 480848/035

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Informed Consent Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

SB 480848/035

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Dataset Specification

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

SB 480848/035

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

Study Of The Effects Of SB 480848 (Darapladib) On The Electrical Conduction Of The Heart

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