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

NCT00411073 | Completed Phase 1

• 1 other identifier: SB 480848/035
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Atherosclerosis

Keywords

darapladib; moxifloxacin; QT study

Outcome Measures

Primary Outcomes (1)

• Change in QTc interval as compared to placebo and moxifloxacin

  throughout the study

Secondary Outcomes (1)

• Change in ECG parameters as compared to placebo and moxifloxacin

  throughout the study

Interventions

Darapladib DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Evansville, Indiana, 47714, United States

Location

Related Links

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

MeSH Terms

Conditions

Atherosclerosis

Interventions

darapladib

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2006
• First Posted: December 13, 2006
• Study Start: December 1, 2006
• Last Updated: October 28, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)