CClinicalTrials.gg
Sign In
CompletedNCT00387257Updated Apr 15, 2015

Effect Of Rilapladib (SB-659032) On Platelet Aggregation

A Phase 1 interventional study of Rilapladib (SB-659032) in Healthy Subjects and Atherosclerosis, sponsored by GlaxoSmithKline. Completed at 1 site in Australia. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-15.

Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Diagnostic

Phase
Phase 1
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Male
01

Study summary

The purpose of this study is to compare the effects of repeat doses of SB-659032 with placebo on platelet aggregation in subjects.

02

Conditions studied

  • Healthy Subjects
  • Atherosclerosis

Browse trials for

Keywords

  • platelet aggregation
  • SB-659032
  • rilapladib
03

In context

Atherosclerosis

1,567 studies on the registry are indexed under Atherosclerosis; 264 are open to participants now.

This study's enrollment of 58 is below the median of 106 across 882 interventional studies indexed under Atherosclerosis.

Browse Atherosclerosis studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Subjects with QTc \< 450 msec as measured at screening.

Exclusion criteria

Exclusion Criteria:

  • History of asthma.
  • Smokers.
05

Study design

Phase
Phase 1
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
58 participants (actual)

Interventions

  • DrugRilapladib (SB-659032)
06

What researchers measure

Primary outcomes

  1. 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 outcomes

  1. 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

07

Study locations

1 site
  • GSK Investigational Site
    Randwick, New South Wales 2031, Australia
08

References and documents

Publications

  • 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. PubMed 24475026 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 15, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00387257
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Oct 12, 2006
Start date
Oct 2006
Primary completion
Apr 2007
Completion
Apr 2007
Last update
Apr 15, 2015

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Atherosclerosis→

Other studies from this sponsor

GlaxoSmithKline

Start the discussion