Clinical trial NCT01188317: A Study of Aleglitazar in Combination With Ibuprofen in Healthy Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-08-25
Enrollment: 44
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: To assess the effect of ibuprofen in combination with aleglitazar on measured glomerular filtration rate
timeFrame: 12 weeks
Secondary outcomes:
measure: To investigate the effect of ibuprofen in combination with aleglitazar on renal plasma flow, filtration fraction and estimated glomerular filtration rate
timeFrame: 12 weeks
measure: To investigate the effect of ibuprofen in combination with aleglitazar on renin-angiotensin system and on anti-diuretic hormone
timeFrame: 12 weeks
measure: To investigate the pharmacokinetics of aleglitazar and ibuprofen when co-administered
timeFrame: 12 weeks
measure: To investigate safety and tolerability of aleglitazar
timeFrame: 12 weeks
measure: To investigate the effect of aleglitazar in combination with ibuprofen on electrolytes and osmolality clearances
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Omaha
country: United States
state: Nebraska
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: