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Completed

NCT Number: NCT00411073

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

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.

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Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Evansville, Indiana, 47714, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Darapladib

Drug

Primary outcomes

  1. Change in QTc interval as compared to placebo and moxifloxacin

    Time frame: throughout the study

Secondary outcomes

  1. Change in ECG parameters as compared to placebo and moxifloxacin

    Time frame: throughout the study

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2006
First posted
Dec 13, 2006
Registry last updated
Oct 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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