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Effect Of Rilapladib (SB-659032) On Platelet Aggregation

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ClinicalTrials.gov Identifier: NCT00387257
Recruitment Status : Completed
First Posted : October 12, 2006
Last Update Posted : April 15, 2015
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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.

Condition or disease Intervention/treatment Phase
Healthy Subjects Atherosclerosis Drug: Rilapladib (SB-659032) Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Diagnostic
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 Start Date : October 2006
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • History of asthma.
  • Smokers.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00387257


Locations
Australia, New South Wales
GSK Investigational Site
Randwick, New South Wales, Australia, 2031
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00387257     History of Changes
Other Study ID Numbers: LP2108364
First Posted: October 12, 2006    Key Record Dates
Last Update Posted: April 15, 2015
Last Verified: April 2015

Keywords provided by GlaxoSmithKline:
platelet aggregation
SB-659032
rilapladib

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases