A Study of Aleglitazar in Combination With Aspirin in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01188304
First received: August 24, 2010
Last updated: July 7, 2014
Last verified: July 2014

August 24, 2010
July 7, 2014
July 2010
October 2010   (final data collection date for primary outcome measure)
To investigate the effect of aleglitazar in combination with aspirin on measured glomerular filtration rate [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01188304 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • To investigate the effect of aleglitazar in combination with aspirin on renin-angiotensin system and on anti-diuretic hormone [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
  • To investigate the effect of aspirin in combination with aleglitazar on platelet function and serum thromboxane B2 [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
  • To investigate the pharmacokinetics of aleglitazar when co-administered with aspirin [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
  • To investigate safety and tolerability of aleglitazar [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
  • To investigate the effect of aleglitazar in combination with aspirin on electrolytes and osmolality clearances [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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 inv estigate the safety and tolerability, and the effect of aleglitazar in combinati on with aspirin on renal function, renin-angiotensin system and platelet aggrega tion 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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Healthy Volunteer
  • Drug: aleglitazar
    repeated daily doses
  • Drug: placebo
    repeated daily doses
  • Drug: aspirin
    repeated daily doses
  • Experimental: 1
    Interventions:
    • Drug: aleglitazar
    • Drug: aspirin
  • Placebo Comparator: 2
    Interventions:
    • Drug: placebo
    • Drug: aspirin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
October 2010
October 2010   (final data collection date for primary outcome measure)

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
Both
40 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01188304
BP25329
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP