Effect Of Rilapladib (SB-659032) On Platelet Aggregation

Atherosclerosis Clinical Trial

Official title:

A Double Blind, Placebo Controlled, Parallel Study to Evaluate Effects of Repeat Doses of Rilapladib on Platelet Aggregation in Healthy Male Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00387257
• Other study ID #: LP2108364
• Status: Completed
• Phase: Phase 1
• First received: October 10, 2006
• Last updated: April 14, 2015
• Start date: October 2006
• Est. completion date: April 2007

Study information

• Verified date: April 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• History of asthma.

• Smokers.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Atherosclerosis
• Healthy Subjects

Intervention

Drug:
• Rilapladib (SB-659032)

Locations

Country	Name	City	State
Australia	GSK Investigational Site	Randwick	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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