NCT00387257

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2006

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 10, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 12, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

April 15, 2015

Status Verified

April 1, 2015

Enrollment Period

6 months

First QC Date

October 10, 2006

Last Update Submit

April 14, 2015

Conditions

Healthy SubjectsAtherosclerosis

Keywords

platelet aggregationSB-659032rilapladib

Outcome Measures

Primary Outcomes (1)

  • 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 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.

    on Day 1 and Day 14 as determined by optical aggregometry

Interventions

Rilapladib (SB-659032)DRUG

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • History of asthma.
  • Smokers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Randwick, New South Wales, 2031, Australia

Location

Related Publications (1)

  • 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.

    PMID: 24475026DERIVED

MeSH Terms

Conditions

Atherosclerosis

Interventions

rilapladib

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2006

First Posted

October 12, 2006

Study Start

October 1, 2006

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

April 15, 2015

Record last verified: 2015-04

Locations

AU(1)