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

Phase 1

Completed

• Conditions: Atherosclerosis

• Registration Number: NCT00411073
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2006-12-12
• Study First Submitted QC: 2006-12-12
• Study First Posted: 2006-12-13
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-27
• Last Update Posted: 2016-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Change in QTc interval as compared to placebo and moxifloxacin	throughout the study

Secondary Outcome Measures

Name	Time	Method
Change in ECG parameters as compared to placebo and moxifloxacin	throughout the study

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Evansville, Indiana, United States