A Study of Aleglitazar in Combination With Ibuprofen in Healthy Volunteers

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteer

In brief

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.

Key facts

Study ID

NCT01188317

Run by

Hoffmann-La Roche

People needed

44

Starts

2010-06-01

Expected to finish

2011-09-01

Last updated by the study team

2012-05-22

Who can join

Age: 40 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

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