Back to resultsEffect Of Rilapladib (SB-659032) On Platelet Aggregation
Primary Purpose
Healthy Subjects, Atherosclerosis
Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
Rilapladib (SB-659032)
Sponsored by
About this trial
This is an interventional diagnostic trial for Healthy Subjects focused on measuring platelet aggregation, SB-659032, rilapladib
Eligibility Criteria
Inclusion Criteria:
- Subjects with QTc < 450 msec as measured at screening.
Exclusion Criteria:
- History of asthma.
- Smokers.
Sites / Locations
- GSK Investigational Site
Outcomes
Primary Outcome Measures
Collagen EC50 values on Day 35 (or 21 days post last dose) as determine by optical aggregometry.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00387257
Brief Title
Effect Of Rilapladib (SB-659032) On Platelet Aggregation
Official Title
A Double Blind, Placebo Controlled, Parallel Study to Evaluate Effects of Repeat Doses of Rilapladib on Platelet Aggregation in Healthy Male Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare the effects of repeat doses of SB-659032 with placebo on platelet aggregation in subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Subjects, Atherosclerosis
Keywords
platelet aggregation, SB-659032, rilapladib
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Rilapladib (SB-659032)
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects with QTc < 450 msec as measured at screening.
Exclusion Criteria:
History of asthma.
Smokers.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
12. IPD Sharing Statement
Citations:
PubMed Identifier
24475026
Citation
Shaddinger BC, Xu Y, Roger JH, Macphee CH, Handel M, Baidoo CA, Magee M, Lepore JJ, Sprecher DL. Platelet aggregation unchanged by lipoprotein-associated phospholipase A(2) inhibition: results from an in vitro study and two randomized phase I trials. PLoS One. 2014 Jan 27;9(1):e83094. doi: 10.1371/journal.pone.0083094. eCollection 2014.
Results Reference
derived
Learn more about this trial
Effect Of Rilapladib (SB-659032) On Platelet Aggregation
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