FindTrial
Sign In

A Study of Aleglitazar in Combination With Ibuprofen in Healthy Volunteers

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01188317
Enrollment
44
Registered
2010-08-25
Start date
2010-06-30
Completion date
2011-09-30
Last updated
2012-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

Brief 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.

Interventions

DRUGaleglitazar

repeated daily doses

DRUGplacebo

repeated daily doses

DRUGibuprofen

repeated daily doses

Sponsors

Hoffmann-La Roche
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
40 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frame
To assess the effect of ibuprofen in combination with aleglitazar on measured glomerular filtration rate12 weeks

Secondary

MeasureTime frame
To investigate the effect of ibuprofen in combination with aleglitazar on renal plasma flow, filtration fraction and estimated glomerular filtration rate12 weeks
To investigate the effect of ibuprofen in combination with aleglitazar on renin-angiotensin system and on anti-diuretic hormone12 weeks
To investigate the pharmacokinetics of aleglitazar and ibuprofen when co-administered12 weeks
To investigate safety and tolerability of aleglitazar12 weeks
To investigate the effect of aleglitazar in combination with ibuprofen on electrolytes and osmolality clearances12 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026