A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Investigate the Effect of Ibuprofen on Top of Multiple Doses of 150 µg Aleglitazar Once Daily on Renal Function, Renin-angiotensin System, and Pharmacokinetics of Both Compounds in Healthy Subjects
| Registry | NCT01188317 |
|---|---|
| Status | Completed |
| Phase | Phase 1 |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 44 (Actual) |
| Sponsor | Hoffmann-La Roche (Industry) |
| Conditions | Healthy Volunteer |
| Interventions | aleglitazar, placebo, ibuprofen (Drug) |
| Dates | start 2010-06-01, completion 2011-09-01, first posted 2010-08-25, last updated 2012-05-22 |
| Locations | 1 site in United States |
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| 1 | Experimental | Drug: aleglitazar; Drug: ibuprofen | |
| 2 | Placebo comparator | Drug: placebo; Drug: ibuprofen |
Sex: All, ages: 40 Years to 65 Years, accepts healthy volunteers
Inclusion Criteria: * Healthy volunteers, aged 40 to 65 years inclusive * Body Mass Index (BMI) between 18 and 35 kg/m2 inclusive * Females of child-bearing potential must be willing to use two acceptable methods of contraception during the study and at least 3 months before start of the study * Non-smoker or currently smoking less than 5 cigarettes (or equivalent amount of other tobacco products) per day and is willing and able to stop smoking during the period in study center * Volunteer drinks no more than 3 cups of coffee, tea or soft drinks per day and is willing and able to stop drinking coffee, tea and soft drinks during the period in study center Exclusion Criteria: * Any clinically relevant abnormal laboratory test results at screening * Volunteer has taken any prescribed, herbal or over-the-counter medication within 2 weeks prior to first dosing * A history of any clinical significant gastro-intestinal, cardiovascular, musculoskeletal, endocrine, hematological, psychiatric, renal, hepatic, bronchopulmonary or neurological conditions or lipid disorders * A positive test for human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B or hepatitis C * History of intolerance to non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin, history of gastric or duodenal ulceration, personal or family history of abnormal clotting or bleeding
| Facility | City | Country | Status |
|---|---|---|---|
| Omaha, Nebraska | United States |