CON Early Phase Services is conducting a research study for healthy adults ages 18-45. This study is being done to test a potential treatment for epileptic conditions.
Vital signs, ECGs, 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
- 3 consecutive overnights
- 3 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 45 (inclusive) years old
- My BMI is between 19.0 and 30.0 (inclusive) and I weigh at least 110 lbs.
- I am a non-smoker and I have not used any tobacco or nicotine-containing products (including cigarettes, chewing tobacco, snuff, nicotine patches, electronic cigarettes). 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 an investigational drug or participated in any clinical study within 30 days prior to first dose
- If Female, I am not pregnant or breastfeeding
- If Female and capable of becoming pregnant, I agree to use a highly effective method of contraception:
- sexual abstinence, defined as restraining from heterosexual intercourse, when this is in line with the preferred and usual lifestyle of the subject
- intrauterine device
- male partner with vasectomy
- double-barrier method (condom with spermicide plus diaphragm or cervical cap or contraceptive sponge [NOTE: sponge only for women who have not given birth])
- hormonal contraceptives alone are not considered an effective method of birth control for female subjects participating in this study
- If Female and not capable of becoming pregnant, I have been postmenopausal for at least 1 year or I am surgically sterile (uterus removed, tubes tied, ovaries removed)
- If Male and I have a partner capable of becoming pregnant, I agree to use a condom and my partner must be willing to use a medically acceptable method of contraception as described above
- If Male, I agree to not donate sperm
- If Male and I have a partner capable of becoming pregnant, my partner must be willing to use a form of contraception as described above
- I am able to communicate effectively in English with the study personnel
- I do not have a history or presence of any clinically significant illness
- I do not have a history of serious head injuries, unexplained fainting or loss of consciousness
- I do not have a history of history of severe allergic reaction (including anaphylaxis) to any food, medication, bee sting, or asthma
- I do not have a recent history of surgery or major trauma and I do not plan to have surgery during the study
- I do not have a recent history of drug abuse or alcoholism or participated in a drub rehabilitation program
- I have not recently used any prescription or over-the-counter medications
- I have not recently had a vaccination
- I have not recently donated blood
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 use and 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.