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
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 April 16, 2014