A Study of Aleglitazar in Combination With Aspirin in Healthy Volunteers

Healthy Volunteer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01188304
• Other study ID #: BP25329
• Status: Completed
• Phase: Phase 1
• First received: August 24, 2010
• Last updated: November 1, 2016
• Start date: July 2010
• Est. completion date: October 2010

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• aleglitazar
repeated daily doses
• aspirin
repeated daily doses
• placebo
repeated daily doses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To investigate the effect of aleglitazar in combination with aspirin on measured glomerular filtration rate		13 weeks	No
Secondary	To investigate the effect of aleglitazar in combination with aspirin on renal plasma flow, filtration fraction and estimated glomerular filtration rate		13 weeks	No
Secondary	To investigate the effect of aleglitazar in combination with aspirin on renin-angiotensin system and on anti-diuretic hormone		13 weeks	No
Secondary	To investigate the effect of aspirin in combination with aleglitazar on platelet function and serum thromboxane B2		13 weeks	No
Secondary	To investigate the pharmacokinetics of aleglitazar when co-administered with aspirin		13 weeks	No
Secondary	To investigate safety and tolerability of aleglitazar		13 weeks	No
Secondary	To investigate the effect of aleglitazar in combination with aspirin on electrolytes and osmolality clearances		13 weeks	No