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

Hoffmann-La Roche0 sites44 target enrollmentJune 2010

ConditionsHealthy Volunteer

Interventionsibuprofen placebo aleglitazar

Drugsaleglitazar placebo ibuprofen

Overview

Phase: Phase 1
Intervention: ibuprofen
Conditions: Healthy Volunteer
Sponsor: Hoffmann-La Roche
Enrollment: 44
Primary Endpoint: To assess the effect of ibuprofen in combination with aleglitazar on measured glomerular filtration rate
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2010

End Date

September 2011

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Eligibility 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

Arms & Interventions

1

Intervention: ibuprofen

2

Intervention: placebo

2

Intervention: ibuprofen

1

Intervention: aleglitazar

Outcomes

Primary Outcomes

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

Time Frame: 12 weeks

Secondary Outcomes

To investigate the effect of ibuprofen in combination with aleglitazar on renal plasma flow, filtration fraction and estimated glomerular filtration rate(12 weeks)
To investigate the effect of ibuprofen in combination with aleglitazar on renin-angiotensin system and on anti-diuretic hormone(12 weeks)
To investigate the pharmacokinetics of aleglitazar and ibuprofen when co-administered(12 weeks)
To investigate safety and tolerability of aleglitazar(12 weeks)
To investigate the effect of aleglitazar in combination with ibuprofen on electrolytes and osmolality clearances(12 weeks)