Effect Of Rilapladib (SB-659032) On Platelet Aggregation

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00387257
First received: October 10, 2006
Last updated: October 9, 2008
Last verified: October 2008
  Purpose

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


Condition Intervention Phase
Healthy Subjects
Drug: Rilapladib (SB-659032)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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:
  • 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 ]

Estimated Enrollment: 84
Study Start Date: October 2006
Intervention Details:
    Drug: Rilapladib (SB-659032)
    Other Name: Rilapladib (SB-659032)
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00387257     History of Changes
Other Study ID Numbers: LP2108364
Study First Received: October 10, 2006
Last Updated: October 9, 2008
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by GlaxoSmithKline:
SB-659032
platelet aggregation
rilapladib

ClinicalTrials.gov processed this record on April 22, 2014