Summary:
ICON Early Phase Services is conducting a research study for healthy adults ages 18-50. This study is being done to test a potential treatment for advanced peripheral artery disease.
Vital signs, ECGs, neurological examinations, physical examinations and pregnancy, drug and alcohol screens will be performed. Blood and urine samples will also be obtained during this study.
Participants will complete:
- 1 screening visit
- 8 consecutive overnights
- 1 outpatient visits
To determine if you fully qualify, it will be necessary to obtain blood samples after an 8- 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 will need to provide medical records at screening.
If you are able to answer “YES” to the following statements, you may qualify for this study.
- I am a healthy adult, meaning no significant medical conditions
- I am between 18 and 50 (inclusive) years old
- My BMI is between 18.0 and 35.0 kg/m² (inclusive) and I do not weigh more than 291 lbs.
- I have not smoked cigarettes recently. I agree not to smoke for the duration of the study and to abide by the rules of the clinic, which is a non-smoking facility.
- I have not received any investigational product within the last 3 months and I am not currently enrolled in a clinical trial involving an investigational product
- If Female, I am not pregnant or breastfeeding. I do not intend to become pregnant while on study.
- If Female and capable of becoming pregnant, I agree to use 2 highly effective methods of birth control during the study and for at least 60 days after last dose. Methods of birth control include:
- Combined (estrogen and progesterone containing) hormonal contraception (oral, intravaginal, transdermal)
- Progesterone-only hormonal contraceptives (oral, injectable)
- Condom plus spermicide
- Vasectomized partner
- Implantable progestogen only hormonal contraception (IUD, intrauterine hormone-releasing system)
- Bilateral tubal occlusion
- Heterosexual abstinence if this is the preferred and usual lifestyle
- If Female and not capable of becoming pregnant, I have been postmenopausal and without menses for at least 1 year or I am surgically sterile (uterus removed, tubes removed, tubes tied, ovaries removed)
- If Male and I have a partner capable of becoming pregnant, I agree to use acceptable contraception during the treatment period and for at least 60 days after the last dose. Acceptable methods of contraception include abstinence, use of a male condom and another contraceptive method used by my female partner. Acceptable methods for females are listed above.
- If Male and my partner is pregnant or breastfeeding, I agree to remain abstinent from intercourse or use a condom
- I am able to communicate effectively in English with the study personnel
- I have not recently used multivitamins/vitamins, herbal supplements, aspirin, diuretics, or other prescription or over-the-counter medications. Please note that Paracetamol, oral NSAIDs, thyroid treatment, oral contraceptives, and estrogen replacement therapy are permitted. Some OTC medications may also be allowed as deemed acceptable by the investigator.
- I do not have a history of any clinically relevant disease or disorder
- I do not use drugs of abuse
- I have not recently donated blood
- My average weekly alcohol usage does not exceed 21 units/week for males or 14 units/week for females
- I do not have a history of alcohol abuse within the previous 12 months
- I have good venous access to allow for blood sampling
It is important to understand that even if you feel that you meet all the above criteria, you are still required to complete the protocol screening procedures. Scheduling a screening appointment does not guarantee that you will qualify for that study. Additionally, subjects are screened on a first come-first served basis and studies may complete enrollment prior to your visit. Additionally, no guarantees can be made regarding group assignments for any particular study. ICON will not assume any liability for lost time, travel or failure to qualify.
To determine if you fully qualify, it will be necessary to obtain blood and urine samples after an 8-hour fast. You have the option of fasting for a blood or urine sample at the screening appointment, or, you may return at a later date for us to obtain these samples.
If you fast, you should refrain from eating or drinking anything (with the exception of water) for 8 hours before your appointment. We will be testing for tobacco drug abuse. Please refrain from consuming alcohol at least 24 hours prior to your screening appointment.
Be sure to bring all of your medications with you to your screening appointment.
Please note, you need to bring a valid, non-expired photo ID with you when you attend your screening visit. We accept a government issued identification card such as a driver's license, state issued ID card, or passport. Also, be advised that we cannot accept a military ID as we are legally prohibited from copying that form of identification for our records. *Note: As of Nov. 01, 2018 our policy has changed and MILITARY IDs ARE NOW ALLOWED. You will be required to show this same photo ID at all study visits.
You will be filling out paperwork for the study. Please arrive at least 30 minutes in advance of your screening appointment. If you are late for your appointment you may not be seen or may need to reschedule.
Be advised that you may need to provide medical records as part of the screening process for this study. If possible, please bring your full medical records with you to your screening appointment. If you cannot bring your records with you, you must provide them before you can admit to the study. Note that full medical records include surgical reports. You will not be allowed to participate in the study without medical records defined as:
- All medical records, including but not limited to: office notes, face sheets, history and physical, consultation notes, inpatient, outpatient and emergency room treatment, all clinical charts, reports, surgical reports, order sheets, progress notes, nurse's notes, social worker records, clinic records, treatment plans, admission records, discharge summaries, reports of consultations, documents, correspondence, test results, statements, questionnaires/histories, from your medical provider(s).
- For females, surgical reports are required as documentation for procedures such as hysterectomy, bilateral oophorectomy and tubal ligation.
Qualified Participants May Receive:
Qualified participants may be compensated up to $3,700 for time and travel.