Last updated: 11/07/2018 18:53:06

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

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GSK study ID
SB 480848/035
See study documents
Clinicaltrials.gov ID
NCT00411073
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

Change in QTc interval as compared to placebo and moxifloxacin

Timeframe: throughout the study

Secondary outcomes:

Change in ECG parameters as compared to placebo and moxifloxacin

Timeframe: throughout the study

Interventions:
Drug: Darapladib
Enrollment:
72
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Atherosclerosis
Product
darapladib
Collaborators
Not applicable
Study date(s)
December 2006 to June 2007
Type
Interventional
Phase
1

Participation criteria

Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
Yes
  • Healthy
  • Body weight greater than 50 kg (110 lbs) and a body mass index between 19 and 30
  • cardiac abnormalities
  • history of asthma or severe allergic reactions
Inclusion and exclusion 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

Trial location(s)

Location
Status
Contact us
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Location
GSK Investigational Site
Evansville, Indiana, United States, 47714
Status
Study Complete
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Study documents

Clinical study report
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2007-24-06

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

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