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Completed

NCT Number: NCT01188317

A Study of Aleglitazar in Combination With Ibuprofen in Healthy Volunteers

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.

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Key information

Conditions

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Omaha, Nebraska, 68154, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

aleglitazar

Drug

repeated daily doses

Placebo

Drug

repeated daily doses

Ibuprofen

Drug

repeated daily doses

Primary outcomes

  1. To assess the effect of ibuprofen in combination with aleglitazar on measured glomerular filtration rate

    Time frame: 12 weeks

Secondary outcomes

  1. 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

  2. To investigate the effect of ibuprofen in combination with aleglitazar on renin-angiotensin system and on anti-diuretic hormone

    Time frame: 12 weeks

  3. To investigate the pharmacokinetics of aleglitazar and ibuprofen when co-administered

    Time frame: 12 weeks

  4. To investigate safety and tolerability of aleglitazar

    Time frame: 12 weeks

  5. To investigate the effect of aleglitazar in combination with ibuprofen on electrolytes and osmolality clearances

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2010
Study completion
2011
First posted
Aug 25, 2010
Registry last updated
May 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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