Clinical trial NCT01188304: A Study of Aleglitazar in Combination With Aspirin in Healthy Volunteers
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Investigate the Effect of 150 µg Aleglitazar Once Daily in Healthy Subjects Treated With 325 mg Aspirin Once Daily on Renal Function, Renin-angiotensin System and Platelet Aggregation
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 aspirin on renal function, renin-angiotensin system and platelet aggregation in healthy volunteers. Volunteers will be randomized to receive daily doses of aleglitazar or placebo in combination with aspirin. 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 investigate the effect of aleglitazar in combination with aspirin on measured glomerular filtration rate
timeFrame: 13 weeks
Secondary outcomes:
measure: To investigate the effect of aleglitazar in combination with aspirin on renal plasma flow, filtration fraction and estimated glomerular filtration rate
timeFrame: 13 weeks
measure: To investigate the effect of aleglitazar in combination with aspirin on renin-angiotensin system and on anti-diuretic hormone
timeFrame: 13 weeks
measure: To investigate the effect of aspirin in combination with aleglitazar on platelet function and serum thromboxane B2
timeFrame: 13 weeks
measure: To investigate the pharmacokinetics of aleglitazar when co-administered with aspirin
timeFrame: 13 weeks
measure: To investigate safety and tolerability of aleglitazar
timeFrame: 13 weeks
measure: To investigate the effect of aleglitazar in combination with aspirin on electrolytes and osmolality clearances
timeFrame: 13 weeks
Other outcomes:
Locations:
city: San Antonio
country: United States
state: Texas
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: