- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00387257
Effect Of Rilapladib (SB-659032) On Platelet Aggregation
April 14, 2015 updated by: GlaxoSmithKline
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
58
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New South Wales
-
Randwick, New South Wales, Australia, 2031
- GSK Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Subjects with QTc < 450 msec as measured at screening.
Exclusion Criteria:
- History of asthma.
- Smokers.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Collagen EC50 values on Day 35 (or 21 days post last dose) as determine by optical aggregometry.
Time Frame: 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 Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
Time Frame: on Day 1 and Day 14 as determined by optical aggregometry
|
on Day 1 and Day 14 as determined by optical aggregometry
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2006
Primary Completion (Actual)
April 1, 2007
Study Completion (Actual)
April 1, 2007
Study Registration Dates
First Submitted
October 10, 2006
First Submitted That Met QC Criteria
October 10, 2006
First Posted (Estimate)
October 12, 2006
Study Record Updates
Last Update Posted (Estimate)
April 15, 2015
Last Update Submitted That Met QC Criteria
April 14, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LP2108364
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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