A Phase 1 interventional study of aleglitazar and placebo in Healthy Volunteer, sponsored by Hoffmann-La Roche. Completed at 1 site in United States. Open to participants aged 40 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-05-22.
Sponsored by Hoffmann-La Roche · Phase 1, Interventional, and Treatment
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.
Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: aleglitazar · Drug: ibuprofen
Drug: placebo · Drug: ibuprofen
repeated daily doses
repeated daily doses
repeated daily doses
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
This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.
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Hoffmann-La Roche