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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aleglitazar | Drug | repeated daily doses |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the effect of ibuprofen in combination with aleglitazar on measured glomerular filtration rate | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To investigate the effect of ibuprofen in combination with aleglitazar on renal plasma flow, filtration fraction and estimated glomerular filtration rate | 12 weeks | |
| To investigate the effect of ibuprofen in combination with aleglitazar on renin-angiotensin system and on anti-diuretic hormone |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Omaha | Nebraska | 68154 | United States |
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| ID | Term |
|---|---|
| C542437 | aleglitazar |
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Drug |
repeated daily doses |
|
| ibuprofen | Drug | repeated daily doses |
|
| 12 weeks |
| To investigate the pharmacokinetics of aleglitazar and ibuprofen when co-administered | 12 weeks |
| To investigate safety and tolerability of aleglitazar | 12 weeks |
| To investigate the effect of aleglitazar in combination with ibuprofen on electrolytes and osmolality clearances | 12 weeks |