This randomized, double-blind, placebo-controlled, parallel group study will investigate the safety and tolerability, and the effect of aleglitazar in combination with ibuprofen on renal function, renin-angiotensin system and pharmacokinetics in healthy volunteers. Volunteers will be randomized to receive daily doses of aleglitazar or placebo in combination with ibuprofen. The anticipated time on study drug is 5 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
44
Unnamed facility
Omaha, Nebraska, United States
To assess the effect of ibuprofen in combination with aleglitazar on measured glomerular filtration rate
Time frame: 12 weeks
To investigate the effect of ibuprofen in combination with aleglitazar on renal plasma flow, filtration fraction and estimated glomerular filtration rate
Time frame: 12 weeks
To investigate the effect of ibuprofen in combination with aleglitazar on renin-angiotensin system and on anti-diuretic hormone
Time frame: 12 weeks
To investigate the pharmacokinetics of aleglitazar and ibuprofen when co-administered
Time frame: 12 weeks
To investigate safety and tolerability of aleglitazar
Time frame: 12 weeks
To investigate the effect of aleglitazar in combination with ibuprofen on electrolytes and osmolality clearances
Time frame: 12 weeks
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