A Study of Aleglitazar in Combination With Ibuprofen in Healthy Volunteers

NCT01188317 | Completed Phase 1

• 1 other identifier: BP25330
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• To assess the effect of ibuprofen in combination with aleglitazar on measured glomerular filtration rate

  12 weeks

Secondary Outcomes (5)

• To investigate the effect of ibuprofen in combination with aleglitazar on renal plasma flow, filtration fraction and estimated glomerular filtration rate

  12 weeks

• To investigate the effect of ibuprofen in combination with aleglitazar on renin-angiotensin system and on anti-diuretic hormone

  12 weeks

• To investigate the pharmacokinetics of aleglitazar and ibuprofen when co-administered

  12 weeks

• To investigate safety and tolerability of aleglitazar

  12 weeks

• To investigate the effect of aleglitazar in combination with ibuprofen on electrolytes and osmolality clearances

  12 weeks

Study Arms (2)

1

EXPERIMENTAL

Drug: aleglitazar; Drug: ibuprofen

2

PLACEBO COMPARATOR

Drug: placebo; Drug: ibuprofen

Interventions

aleglitazar DRUG

repeated daily doses

1

placebo DRUG

repeated daily doses

2

ibuprofen DRUG

repeated daily doses

1; 2

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Omaha, Nebraska, 68154, United States

Location

MeSH Terms

Interventions

aleglitazar; Ibuprofen

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 24, 2010
• First Posted: August 25, 2010
• Study Start: June 1, 2010
• Study Completion: September 1, 2011
• Last Updated: May 22, 2012

Record last verified: 2012-05

Locations

US (1)