Status:
COMPLETED
A Study of Aleglitazar in Combination With Ibuprofen in Healthy Volunteers
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Healthy Volunteer
Eligibility:
All Genders
40-65 years
Phase:
PHASE1
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, ren...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01188317
Start Date
June 1 2010
End Date
September 1 2011
Last Update
May 22 2012
Active Locations (1)
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1
Omaha, Nebraska, United States, 68154