Roche trials database

Trial information

A Study of Aleglitazar in Combination With Aspirin in Healthy Volunteers

Status:

Completed

Protocol number:

BP25329

Sponsor:

Hoffmann-La Roche

Company division:

Pharmaceutical

Official Scientific 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

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. Target sample size is 44.

Study phase:

I

Study type:

Interventional; Treatment; Randomized; Double Blind; Parallel; Safety/efficacy study

Conditions:

• Healthy Volunteer

Primary outcome:

1. To investigate the effect of aleglitazar in combination with aspirin on measured glomerular filtration rate Time frame: 13 weeks

Key secondary outcomes:

1. To investigate the effect of aleglitazar in combination with aspirin on renal plasma flow, filtration fraction and estimated glomerular filtration rate Time frame: 13 weeks
2. To investigate the effect of aleglitazar in combination with aspirin on renin-angiotensin system and on anti-diuretic hormone Time frame: 13 weeks
3. To investigate the effect of aspirin in combination with aleglitazar on platelet function and serum thromboxane B2 Time frame: 13 weeks
4. To investigate the pharmacokinetics of aleglitazar when co-administered with aspirin Time frame: 13 weeks
5. To investigate safety and tolerability of aleglitazar Time frame: 13 weeks
6. To investigate the effect of aleglitazar in combination with aspirin on electrolytes and osmolality clearances Time frame: 13 weeks

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

Gender:

Males or Females

Age limits:

Min: 40 years Max: 65 years

Accepts healthy volunteers:

Yes

Anticipated start date:

July, 2010

Trial registration date:

09.08.2010

Date last updated:

10.06.2013

This trial was conducted at the following locations:

U.S.A.

• SAN ANTONIO, TX

Link to trial result