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CompletedNCT01188317Updated May 22, 2012

A Study of Aleglitazar in Combination With Ibuprofen in Healthy Volunteers

A Phase 1 interventional study of aleglitazar and placebo in Healthy Volunteer, sponsored by Hoffmann-La Roche. Completed at 1 site in United States. Open to participants aged 40 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-05-22.

Sponsored by Hoffmann-La Roche · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
40 Years to 65 Years
Sex
All
01

Study 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, 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.

02

Conditions studied

  • Healthy Volunteer
03

In context

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 65 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
44 participants (actual)

Study arms

  • Experimental
    1

    Drug: aleglitazar · Drug: ibuprofen

  • Placebo comparator
    2

    Drug: placebo · Drug: ibuprofen

Interventions

  • Drugaleglitazar

    repeated daily doses

  • Drugplacebo

    repeated daily doses

  • Drugibuprofen

    repeated daily doses

06

What researchers measure

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

07

Study locations

1 site
  • Omaha, Nebraska 68154, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01188317
Lead sponsor
Hoffmann-La Roche
First posted
Aug 25, 2010
Start date
Jun 2010
Completion
Sep 2011
Last update
May 22, 2012

Study contacts

Clinical Trials
study director · Hoffmann-La Roche
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.

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