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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 August 27, 2014