A Study of Aleglitazar in Combination With Aspirin in Healthy Volunteers
- Registration Number
- NCT01188304
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 aleglitazar - 2 aspirin - 2 placebo - 1 aspirin -
- Primary Outcome Measures
Name Time Method To investigate the effect of aleglitazar in combination with aspirin on measured glomerular filtration rate 13 weeks
- Secondary Outcome Measures
Name Time Method To investigate safety and tolerability of aleglitazar 13 weeks 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 pharmacokinetics of aleglitazar when co-administered with aspirin 13 weeks To investigate the effect of aleglitazar in combination with aspirin on electrolytes and osmolality clearances 13 weeks To investigate the effect of aspirin in combination with aleglitazar on platelet function and serum thromboxane B2 13 weeks