ICON Development Solutions is recruiting healthy men and women ages 40-65 to participate in a medical research study to assess the effects of ibuprofen in combination with multiple doses of aleglitazar on kidney function in healthy subjects, as well as to evaluate its safety and tolerability. Aleglitazar is being developed for the reduction of cardiovascular mortality in adults with Type 2 Diabetes, and has been well tolerated in previous clinical studies in both healthy volunteers and in patients with Type 2 Diabetes. 

 

  

Screening Visit:             Thurs, 02-Sep-2010 (by appointment)

Check In:                        Thurs, 09-Sep-2010 (8 a.m.)                                 

Release:                        Mon, 13-Sep-2010 (appr. 10:30 a.m.)                                              

Return Visit:                    Mon, 20-Sep-2010 (8 a.m. – appr. 10:30 a.m.)

Return Visit:                   Mon, 27-Sep-2010 (8 a.m. – appr. 10:30 a.m.)

Return Visit:                    Mon, 04-Oct-2010 (8 a.m. – appr. 10:30 a.m.)

Check In:                         Thurs, 07-Oct-2010 (8 a.m.)

Release:                          Fri, 15-Oct-2010 (appr. 3:30 p.m.)

Return Visit:                    Fri, 22-Oct-2010 (8 a.m. – appr. 10:30 a.m.)

Return Visit:                    Fri, 29-Oct-2010 (8 a.m. – appr. 10:30 a.m.)

Return Visit:                    Fri, 05-Nov-2010 (8 a.m. – appr. 10:30 a.m.)

 

 

1.        Healthy male or female aged 40 to 65 at the time of screening for this study.

2.        Have a body mass index (BMI) between 18 and 35 kg/m²

3.        Females must meet one of the following: 

·          Surgically sterile (by means of hysterectomy, removal of both ovaries, or tubal ligation)

·          Post Menopausal (no menses for at least 1 year) confirmed by follicle simulating hormone (FSH) and estradiol if not on hormone replacement therapy

·          Willing to use two acceptable methods of contraception for the duration of the study and for 3 months after the last dose of study medication. Acceptable methods include:

-           barrier-type devices such as condom or diaphragm

-           intrauterine devices

-           hormonal contraceptive agents, levonorgestrel implants, depots or Nuvaring started at least 90 days before start of study

Please note: Abstention, the rhythm method, or contraception by the partner are NOT acceptable methods of contraception.   
 

4.        Non-Smoker or currently smoking less than five cigarettes or the equivalent amount of tobacco per day and willing and able to stop smoking or using any nicotine-containing products during the residential periods of the study.

5.        Normally drink no more than three cups of coffee, tea, caffeinated soft drinks per day

6.        Willing to stop drinking coffee, tea, and caffeinated soft drinks for the duration of the study

7.        Able to participate and willing to give written informed consent and to comply with the study restrictions and requirements. 

1.   Any clinically relevant abnormal laboratory test results at screening or on
Day -4 (day of first check in), as judged by the Investigator.

2.   Have taken any prescribed or herbal/OTC medication within 2 weeks prior to the
      first dosing with the exception of the following:

·          Hormonal contraceptives and HRTs allowed

·          Acetaminophen allowed up to a maximum dose of 2 g/day up to 24 hours prior to dosing, not to exceed 4 g total during the week prior to dosing

·          Commonly used vitamins allowed up to 2 days before dosing

3.        A history of clinically significant conditions of the stomach, heart, muscles, bones, glands, blood, mind, kidney, liver, lungs, nervous system, or lipid metabolism disorders.  

4.        A positive serology test for human immunodeficiency virus (HIV)-1 or HIV-2, hepatitis B or hepatitis C at screening

5.        An average alcohol intake of more than 14 units per week. One unit of alcohol is defined as:

a.        Beer: ½ pint or 9.6 oz. (not a full 12 oz. can)

b.        Spirits: .8 oz or 1.7 TBS (just smaller than a dosing cup that comes with cough syrup)

c.        Wine: 4.2 oz.                

6.        A positive screen for drugs of abuse or alcohol breath test

7.        Acute infection or current malignancy requiring treatment, with the exception of an excised basal cell carcinoma

8.        Supine blood pressure > 140/90 mmHg or < 90/50 mmHg or pulse rate > 100 or < 45 beats per minute

9.        A history of clinically significant allergic disease or drug hypersensitivity according to the Investigator’s clinical judgment

10.    Any significant donation/loss of blood or plasma (>450 m) within 3 months prior to screening

11.    Any other condition or disease of which in the opinion of the Investigator, would place the subject at undue risk, or interfere with study data or the ability of the subject to complete the study.

12.    Has participated in a clinical study with an investigational drug or new chemical entity within 60 days prior to screening

13.    History of intolerance to NSAIDs or aspirin, history of gastric or stomach ulcers, or personal or family history of abnormal clotting or bleeding.

14.    Use of a known inhibitor or inducer of the study medications (CYP 2C8 or CYP2C19) within 4 weeks of the first dose of study medication

15.    Known history of hypersensitivity to aleglitazar and its components, iohexol or iodine products.

16.    Known history of severe allergies to foods or drugs or subjects requiring regular use of antihistamines

17.    Inadequate venous access for the study procedures, in the opinion of the Investigator

18.    Female subjects who are pregnant or lactating

19.    Consumption of grapefruit, grapefruit juice and/or Seville oranges 48 hours prior to first admission to the study unit

20.    Consumption of foods containing poppy seeds 1 week prior to study start

 

It is important to understand that even if you feel that you meet all the above criteria, you are still required to attend a screening visit (by appointment only) to ensure that you meet the study protocol requirements. Screening visits typically include Informed Consent, collection of your medical history, vital signs, temperature, height, weight, ECG, physical examination, and a urine and blood sample to test for drugs, alcohol, and nicotine. Lab tests will also be ran after your screening visit to assess your study qualification. 

 

Scheduling a screening appointment does not guarantee that you will qualify for the study.

 

Additionally, more subjects are screened than are necessary to ensure full enrollment. Therefore, passing screening procedures does not guarantee you a spot on the study. You will be schedule a time to call for your screening results, and at that time will be informed whether you were selected at random from the pool of qualified participants. This qualification process is also outlined in the Volunteer Rules which will be provide to you after your screening appointment has been scheduled, as well as at your screening appointment. 

 

 

If you feel you are eligible for this study based on the qualification criteria outlined above, and you are interested in scheduling a screening appointment, please use our Online Scheduler by clicking on the following link:  

 

 

 

 

 

Notice:

 

In order to schedule a screening appointment online, you will be required to enter your personal information (name, DOB, etc.) into a secure, password protected database. Your information will remain confidential and will not be accessible by any party that does not work directly for ICON Development Solutions. It may be necessary for the recruitment staff to contact you by phone in the event of a schedule change or if more information is needed. You have the right to remove your information from the database at anytime by logging in to the scheduling program and choosing “My Profile” and then selecting the “Terminate Account” button.