Atherosclerosis Clinical Trial
Official title:
A Double Blind, Placebo Controlled, Parallel Study to Evaluate Effects of Repeat Doses of Rilapladib on Platelet Aggregation in Healthy Male Volunteers
The purpose of this study is to compare the effects of repeat doses of SB-659032 with placebo on platelet aggregation in subjects.
Status | Completed |
Enrollment | 58 |
Est. completion date | April 2007 |
Est. primary completion date | April 2007 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: - Subjects with QTc < 450 msec as measured at screening. Exclusion Criteria: - History of asthma. - Smokers. |
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Australia | GSK Investigational Site | Randwick | New South Wales |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Collagen EC50 values on Day 35 (or 21 days post last dose) as determine by optical aggregometry. | on Day 35 (or 21 days post last dose) as determine by optical aggregometry | ||
Secondary | Collagen EC50 values on Day 1 and Day 14 as determined by optical aggregometry Plasma Lp-PLA2 activity Clinical safety data Concentrations of rilapladib and SB-664601. | on Day 1 and Day 14 as determined by optical aggregometry |
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