A Study of Aleglitazar in Combination With Ibuprofen in Healthy Volunteers

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

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.

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