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A Study of Aleglitazar in Combination With Ibuprofen in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01188317
First received: August 24, 2010
Last updated: May 21, 2012
Last verified: May 2012
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • To investigate the effect of ibuprofen in combination with aleglitazar on renin-angiotensin system and on anti-diuretic hormone [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • To investigate the pharmacokinetics of aleglitazar and ibuprofen when co-administered [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • To investigate safety and tolerability of aleglitazar [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • To investigate the effect of aleglitazar in combination with ibuprofen on electrolytes and osmolality clearances [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01188317

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

No publications provided

Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01188317     History of Changes
Other Study ID Numbers: BP25330
Study First Received: August 24, 2010
Last Updated: May 21, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 19, 2013