A Study of Aleglitazar in Combination With Ibuprofen in Healthy Volunteers

Healthy Volunteer Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Investigate the Effect of Ibuprofen on Top of Multiple Doses of 150 µg Aleglitazar Once Daily on Renal Function, Renin-angiotensin System, and Pharmacokinetics of Both Compounds in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01188317
• Other study ID #: BP25330
• Status: Completed
• Phase: Phase 1
• First received: August 24, 2010
• Last updated: May 21, 2012
• Start date: June 2010
• Est. completion date: September 2011

Study information

• Verified date: May 2012
• 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 ibuprofen on renal function, renin-angiotensin system and pharmacokinetics in healthy volunteers. Volunteers will be randomized to receive daily doses of aleglitazar or placebo in combination with ibuprofen. The anticipated time on study drug is 5 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: September 2011
• 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
• placebo
repeated daily doses
• ibuprofen
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 assess the effect of ibuprofen in combination with aleglitazar on measured glomerular filtration rate		12 weeks	No
Secondary	To investigate the effect of ibuprofen in combination with aleglitazar on renal plasma flow, filtration fraction and estimated glomerular filtration rate		12 weeks	No
Secondary	To investigate the effect of ibuprofen in combination with aleglitazar on renin-angiotensin system and on anti-diuretic hormone		12 weeks	No
Secondary	To investigate the pharmacokinetics of aleglitazar and ibuprofen when co-administered		12 weeks	No
Secondary	To investigate safety and tolerability of aleglitazar		12 weeks	No
Secondary	To investigate the effect of aleglitazar in combination with ibuprofen on electrolytes and osmolality clearances		12 weeks	No