NCT01188317CompletedPhase 1
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
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 44
- Primary Endpoint
- To assess the effect of ibuprofen in combination with aleglitazar on measured glomerular filtration rate
Study Overview
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 40 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
1
Experimental
Intervention: ibuprofen (Drug)
2
Placebo Comparator
Intervention: placebo (Drug)
2
Placebo Comparator
Intervention: ibuprofen (Drug)
1
Experimental
Intervention: aleglitazar (Drug)
Outcomes
Primary Outcomes
To assess the effect of ibuprofen in combination with aleglitazar on measured glomerular filtration rate
Time Frame: 12 weeks
Secondary Outcomes
- 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)
Investigators
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