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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00411073
First received: December 12, 2006
Last updated: October 9, 2008
Last verified: October 2008
  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 1

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:


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:
    Drug: Darapladib
    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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Arteriosclerosis
Atherosclerosis
Arterial Occlusive Diseases
Cardiovascular Diseases
Vascular Diseases
Darapladib
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Phospholipase A2 Inhibitors

ClinicalTrials.gov processed this record on November 20, 2014