Atherosclerosis
Conditions
Keywords
darapladib, moxifloxacin, QT study
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.
Interventions
DRUGDarapladib
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in QTc interval as compared to placebo and moxifloxacin | throughout the study |
Secondary
| Measure | Time frame |
|---|---|
| Change in ECG parameters as compared to placebo and moxifloxacin | throughout the study |
Countries
United States
Outcome results
None listed