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A Study of Aleglitazar in Combination With Ibuprofen in Healthy Volunteers

This study has been completed.
Information provided by:
Hoffmann-La Roche Identifier:
First received: August 24, 2010
Last updated: May 21, 2012
Last verified: May 2012
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.

Condition Intervention Phase
Healthy Volunteer
Drug: aleglitazar
Drug: placebo
Drug: ibuprofen
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • To assess the effect of ibuprofen in combination with aleglitazar on measured glomerular filtration rate [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • To investigate the effect of ibuprofen in combination with aleglitazar on renal plasma flow, filtration fraction and estimated glomerular filtration rate [ Time Frame: 12 weeks ]
  • To investigate the effect of ibuprofen in combination with aleglitazar on renin-angiotensin system and on anti-diuretic hormone [ Time Frame: 12 weeks ]
  • To investigate the pharmacokinetics of aleglitazar and ibuprofen when co-administered [ Time Frame: 12 weeks ]
  • To investigate safety and tolerability of aleglitazar [ Time Frame: 12 weeks ]
  • To investigate the effect of aleglitazar in combination with ibuprofen on electrolytes and osmolality clearances [ Time Frame: 12 weeks ]

Enrollment: 44
Study Start Date: June 2010
Study Completion Date: September 2011
Arms Assigned Interventions
Experimental: 1 Drug: aleglitazar
repeated daily doses
Drug: ibuprofen
repeated daily doses
Placebo Comparator: 2 Drug: placebo
repeated daily doses
Drug: ibuprofen
repeated daily doses


Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Sexes Eligible for Study:   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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01188317

United States, Nebraska
Omaha, Nebraska, United States, 68154
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Disclosures Group, Hoffmann-La Roche Identifier: NCT01188317     History of Changes
Other Study ID Numbers: BP25330
Study First Received: August 24, 2010
Last Updated: May 21, 2012

Additional relevant MeSH terms:
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 23, 2017