Alzheimer's Disease Clinical Trial
Official title:
A Phase I, Two-part, Open-label Study to Evaluate the Pharmacokinetics of Rilapladib (SB-659032) and Its Metabolites, and to Determine the Effect of Repeat Dose Itraconazole on the Pharmacokinetics of Rilapladib in Healthy Volunteers
Rilapladib is a potent and selective inhibitor of lipoprotein associated phospholipase A2
(Lp-PLA2), which was previously under development for the treatment of atherosclerosis and
is currently being developed for the treatment of Alzheimer's disease.
This study is a single-center, open-label, two-part study. The two study parts will run
independently. Subjects dosed in one part of this study will not be permitted to participate
in the other part.
Part A will investigate the pharmacokinetic profile of rilapladib and its metabolites,
SB-664601 and GSK1174379, after single dose and steady state dosing of rilapladib 250
milligram (mg) along with the biliary and urinary elimination pathways of rilapladib 250 mg.
Part B will determine the effect of repeat administration of itraconazole on the PK of a
single oral dose of rilapladib 25 mg.
Healthy male and female subjects, aged 18-65 years, will be recruited for this study. Ten
subjects will be recruited for Part A and 20 subjects will be recruited for Part B.
n/a
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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