A Study of Aleglitazar in Combination With Aspirin 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 aspirin on renal function, renin-angiotensin system and platelet aggregation in healthy volunteers. Volunteers will be randomized to receive daily doses of aleglitazar or placebo in combination with aspirin. 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 150 µg Aleglitazar Once Daily in Healthy Subjects Treated With 325 mg Aspirin Once Daily on Renal Function, Renin-angiotensin System and Platelet Aggregation

Conditions
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Healthy Volunteer

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


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: aspirin<br>* repeated daily doses<br>|
| Placebo Comparator: 2<br> | Drug: aspirin<br>* repeated daily doses<br>Drug: placebo<br>* repeated daily doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the effect of aleglitazar in combination with aspirin on measured glomerular filtration rate |  | 13 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the effect of aleglitazar in combination with aspirin on renal plasma flow, filtration fraction and estimated glomerular filtration rate |  | 13 weeks | 
| To investigate the effect of aleglitazar in combination with aspirin on renin-angiotensin system and on anti-diuretic hormone |  | 13 weeks | 
| To investigate the effect of aspirin in combination with aleglitazar on platelet function and serum thromboxane B2 |  | 13 weeks | 
| To investigate the pharmacokinetics of aleglitazar when co-administered with aspirin |  | 13 weeks | 
| To investigate safety and tolerability of aleglitazar |  | 13 weeks | 
| To investigate the effect of aleglitazar in combination with aspirin on electrolytes and osmolality clearances |  | 13 weeks |