This randomized, double-blind, placebo-controlled, parallel group study will investigate the safety and tolerability, and the effect of aleglitazar in combination with aspirin on renal function, renin-angiotensin system and platelet aggregation in healthy volunteers. Volunteers will be randomized to receive daily doses of aleglitazar or placebo in combination with aspirin. The anticipated time on study drug is 5 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
44
Unnamed facility
San Antonio, Texas, United States
To investigate the effect of aleglitazar in combination with aspirin on measured glomerular filtration rate
Time frame: 13 weeks
To investigate the effect of aleglitazar in combination with aspirin on renal plasma flow, filtration fraction and estimated glomerular filtration rate
Time frame: 13 weeks
To investigate the effect of aleglitazar in combination with aspirin on renin-angiotensin system and on anti-diuretic hormone
Time frame: 13 weeks
To investigate the effect of aspirin in combination with aleglitazar on platelet function and serum thromboxane B2
Time frame: 13 weeks
To investigate the pharmacokinetics of aleglitazar when co-administered with aspirin
Time frame: 13 weeks
To investigate safety and tolerability of aleglitazar
Time frame: 13 weeks
To investigate the effect of aleglitazar in combination with aspirin on electrolytes and osmolality clearances
Time frame: 13 weeks
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