Summary:
ICON Early Phase Services is conducting a research study for healthy adults ages 51-70. 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
- 2 consecutive overnights
- 1 outpatient visit
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. For more information, see below.
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
- 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, prescription or over-the-counter medications. Paracetamol, oral NSAIDs, thyroid treatment, oral contraceptives, estrogen replacement therapy, statins and anti-hypertensives 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 under 64 or 14 units/week for females and males ≥65
- I do not have a history of alcohol abuse within the previous 12 months
- I have good venous access to allow for blood sampling
Qualified Participants May Receive:
Qualified participants may be compensated up to $1,125 for time and travel.