Summary:
ICON Early Phase Services is looking for healthy men for a clinical research study. This study is being done to test an investigational product for glycemic control and body weight reduction. The study drug will be administered orally.
The very first appointment will be the information session where you will be given information about the study. Please note, you do not have to fast for the information visit. You will have the opportunity to ask questions and receive further information on the study and you will also be given an informed consent form. No study procedures will be performed at this first appointment and no fasting is required for the information session appointment. After you receive information on the study and have the opportunity to ask your questions, you may either decline participation in the study or agree to participate and sign the study informed consent form. If you agree to participate in the study, the study staff will schedule with you a screening visit appointment and will provide you with the requirements for the screening visit, inform you about what procedures will be done at the screening visit, and will discuss with you about what medical records and documents you should bring to the screening visit.
Please review the information below and determine whether you are interested in the study and would like to schedule your information session appointment.
Vital signs, ECGs, physical examinations, and drug and alcohol screens will be performed during the study. Blood and urine samples will also be obtained during this study.
After the information session appointment and if you agree to participate in the study and sign the study informed consent, you will be invited and scheduled to complete a screening visit.
To determine if you fully qualify, it will be necessary to obtain blood samples after a recommended 10- hour fast. You have the option of fasting for the screening appointment, or, you may return at a later date. If ICON does not have your medical records on file, you may need to provide medical records at screening. For more information, see below.
If you qualify to participate in the study, your participation will take approximately 9 weeks and you will need to attend:
- information visit
- screening visit
- 5 consecutive overnights
- 7 outpatient visits
If you are able to answer “YES” to the following statements, you may qualify for this study.
- My BMI is between 20.0 and 29.9 kg/m2 (inclusive)
- I do not smoke, or, I do not smoke more than 1 cigarette/day. I agree not to smoke while in-house and to abide by the rules of the clinic, which is a non-smoking facility.
- I have not received any investigational medicinal product within 60 days before screening
- I agree not to participate in another clinical trial while participating in this trial
- I am able to communicate effectively in English with the study personnel
- I am sexually abstinent, surgically sterilized (vasectomy), OR, I agree to use a highly effective method of contraception if I am sexually active with a non-pregnant female partner
- I have not used prescription medicinal products or non-prescription drugs, (except routine vitamins, naproxen, acetaminophen, ibuprofen, acetylsalicylic acid, or non-systemic topical medications) within 14 days prior to the day of screening
- I have not had previous exposure to GLP-1 receptor agents (e.g., Byetta, Victoza, etc.)
- I do not anticipate a change in lifestyle (e.g., eating, exercise or sleeping pattern) during the study
- I do not have any history of psychiatric disorders (e.g., schizophrenia, bipolar disorder, eating disorders, depression or anxiety)
- I do not have a history of any severe allergies (e.g., medications, foods, latex) or a history of anaphylactic reactions
- I do not have a history of alcohol abuse within 1 year of screening and my daily alcohol intake is no more than 24g of alcohol/day
- I do not have a history of drug abuse/chemical substance abuse within 1 year prior to screening
- I have not donated blood or plasma within 90 days of screening
- I do not have clinically significant gastrointestinal disorders
- I do not have a presence or history of pancreatitis (acute or chronic)
- I have not had any gastric surgery such as total gastrectomy, sleeve gastrectomy or gastric bypass surgery
- I agree to consume no more than 8 cups of coffee, tea, soda, mate, guarana, chocolate beverages or foods per day while on study
- I agree not to take St. John’s wort while on study
- I agree not to consume grapefruit, cranberries, grapefruit juice and cranberry juice while on study
- I agree to avoid any strenuous physical exercise (e.g. weight training, aerobics or team sports) while on study
- I do not have any special diet requirements and I am willing to eat the food provided while on-site and for overnight stays
- I have not had problems having blood drawn in either arm, venous access or finger pricks.
If you qualify to participate in the study, your participation will take approximately 9 weeks and you will need to attend:
- information visit
- screening visit
- 5 consecutive overnights
- 7 outpatient visits
Qualified Participants May Receive:
Compensation up to $4,000