Last updated: 11/04/2018 08:54:38
Effect Of Rilapladib (SB-659032) On Platelet Aggregation
GSK study ID
LP2108364
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Double Blind, Placebo controlled, Parallel Study to Evaluate Effects of Repeat Doses of Rilapladib on Platelet Aggregation in Healthy Male Volunteers
Trial description: The purpose of this study is to compare the effects of repeat doses of SB-659032 with placebo on platelet aggregation in subjects.
Primary purpose:
Diagnostic
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Collagen EC50 values on Day 35 (or 21 days post last dose) as determine by optical aggregometry.
Timeframe: on Day 35 (or 21 days post last dose) as determine by optical aggregometry
Secondary outcomes:
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.
Timeframe: on Day 1 and Day 14 as determined by optical aggregometry
Interventions:
Drug: Rilapladib (SB-659032)
Enrollment:
58
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Healthy Subjects, Atherosclerosis
Product
rilapladib
Collaborators
Not applicable
Study date(s)
October 2006 to April 2007
Type
Interventional
Phase
1
Participation criteria
Sex
Male
Age
18 - 55 years
Accepts healthy volunteers
Yes
- Subjects with QTc < 450 msec as measured at screening.
- History of asthma.
- Smokers.
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects with QTc < 450 msec as measured at screening.
Exclusion criteria:
- History of asthma.
- Smokers.
Trial location(s)
Location
GSK Investigational Site
Randwick, New South Wales, Australia, 2031
Status
Study Complete
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2007-26-04
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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