A Study of Aleglitazar in Combination With Aspirin in Healthy Volunteers

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: aleglitazar; Drug: aspirin; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78209

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: aleglitazar; repeated daily doses; Drug: aspirin; repeated daily doses
Placebo Comparator: 2	Drug: aspirin; repeated daily doses; Drug: placebo; repeated daily doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To investigate the effect of aleglitazar in combination with aspirin on measured glomerular filtration rate	13 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
To investigate the effect of aleglitazar in combination with aspirin on renal plasma flow, filtration fraction and estimated glomerular filtration rate	13 weeks
To investigate the effect of aleglitazar in combination with aspirin on renin-angiotensin system and on anti-diuretic hormone	13 weeks
To investigate the effect of aspirin in combination with aleglitazar on platelet function and serum thromboxane B2	13 weeks
To investigate the pharmacokinetics of aleglitazar when co-administered with aspirin	13 weeks
To investigate safety and tolerability of aleglitazar	13 weeks
To investigate the effect of aleglitazar in combination with aspirin on electrolytes and osmolality clearances	13 weeks

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: August 24, 2010
• First Submitted That Met QC Criteria: August 24, 2010
• First Posted (Estimate): August 25, 2010

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: BP25329