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
  Purpose

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.


Condition Intervention Phase
Healthy Volunteer
Drug: aleglitazar
Drug: placebo
Drug: aspirin
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • To investigate the effect of aleglitazar in combination with aspirin on measured glomerular filtration rate [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 44
Study Start Date: July 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: aleglitazar
repeated daily doses
Drug: aspirin
repeated daily doses
Placebo Comparator: 2 Drug: placebo
repeated daily doses
Drug: aspirin
repeated daily doses

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01188304

Locations
United States, Texas
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01188304     History of Changes
Other Study ID Numbers: BP25329
Study First Received: August 24, 2010
Last Updated: July 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 26, 2014