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

This study has been completed.

First Received on December 12, 2006. Last Updated on October 9, 2008 History of Changes

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00411073

Purpose

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.

Condition	Intervention	Phase
Atherosclerosis	Drug: Darapladib	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Atherosclerosis

Drug Information available for: Moxifloxacin Moxifloxacin hydrochloride Darapladib

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Change in QTc interval as compared to placebo and moxifloxacin [ Time Frame: throughout the study ]

Secondary Outcome Measures:

Change in ECG parameters as compared to placebo and moxifloxacin [ Time Frame: throughout the study ]

Estimated Enrollment:	72
Study Start Date:	December 2006

Intervention Details:

Other Name: Darapladib

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00411073

Locations

United States, Indiana
GSK Investigational Site
Evansville, Indiana, United States, 47714

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Study Director, GSK
ClinicalTrials.gov Identifier:	NCT00411073 History of Changes
Other Study ID Numbers:	SB 480848/035
Study First Received:	December 12, 2006
Last Updated:	October 9, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

QT study
darapladib
moxifloxacin

Additional relevant MeSH terms:

Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

Moxifloxacin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012