A study in patients with atherosclerosis to assess safety, effect and PK of rilapladib vs. placebo over 12 weeks of dosing.
Study LP2105521 is a randomized, double-blind, placebo-controlled, parallel-group study to examine the safety, tolerability, and effects of rilapladib on plasma Lp-PLA2 activity, plaque inflammation, and PAF (if feasible). Subjects will receive placebo or rilapladib once daily for 12 weeks. The study will be conducted in subjects with established atherosclerosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
83
GSK Investigational Site
Boston, Massachusetts, United States
GSK Investigational Site
Brockton, Massachusetts, United States
GSK Investigational Site
Haverhill, Massachusetts, United States
Safety from AE reporting, vital signs, clinical labs, ECGs, slit lamp eye exams and electron microscopy of peripheral blood lymphocytes.
Time frame: 12 weeks
LP-PLA2 activity;
Time frame: 12 weeks
changes in mean standard values of 18 FDG uptake as assessed by PET and MRI imaging
Time frame: 12 weeks
Estimation of PK parameters (such as: apparent volume of distribution, apparent clearance, etc.) of rilapladib and their associated variability, appropriate to the final model
Time frame: 12 weeks
Estimation of PK/PD parameters (such as: IC50, Eo) and their associated variability, appropriate to the final model
Time frame: 12 weeks
24 hour ambulatory blood pressure monitoring
Time frame: 12 weeks
PAF levels in human plasma as feasible
Time frame: 12 weeks
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GSK Investigational Site
Linden, New Jersey, United States
GSK Investigational Site
New York, New York, United States
GSK Investigational Site
New York, New York, United States
GSK Investigational Site
New York, New York, United States
GSK Investigational Site
New York, New York, United States
GSK Investigational Site
North Massapequa, New York, United States
GSK Investigational Site
Warwick, Rhode Island, United States