A Study of Aleglitazar in Combination With Ibuprofen in Healthy Volunteers

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: aleglitazar
* Drug: placebo
* Drug: ibuprofen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: aleglitazar<br>* repeated daily doses<br>Drug: ibuprofen<br>* repeated daily doses<br>|
| Placebo Comparator: 2<br> | Drug: placebo<br>* repeated daily doses<br>Drug: ibuprofen<br>* repeated daily doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the effect of ibuprofen in combination with aleglitazar on measured glomerular filtration rate |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 |