ICON Early Phase Services is conducting a research study for healthy adults ages 18-65. This study is being done to test a potential treatment for neurodegenerative diseases (e.g., Parkinson's and Alzheimer's).
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
• 13 overnights (several periods)
• 15 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 65 (inclusive) years old
• My BMI is between 18.5 and 32.0 kg/m2 at screening and check-in
• I do not smoke and I have not used any form of tobacco or nicotine
containing product in the last 6 months
- 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 drug, or participated in any clinical research study, within 60 days of first dose
• If Female, I am not pregnant or breastfeeding
• If Female and capable of becoming pregnant, I agree to use a medically acceptable method of birth control from screening through 30 days after last dose. Methods of birth control include:
o Abstinence from heterosexual intercourse, when it is in line with the preferred and usual lifestyle of the subject
o Monogamous relationship with a male partner who has had a vasectomy
o Barrier method (e.g., condom or occlusive cap) with spermicidal foam/gel/film/ cream AND either hormonal contraception ( oral, implanted, or injectable) or an intrauterine device or system
- If Female and not capable of becoming pregnant, I have been postmenopausal for at least 12 consecutive months or I am surgically sterile (ovaries removed, OR tubes removed, OR tubes cauterized, OR uterus removed, OR tubes tied)
• If Male and I have a partner capable of becoming pregnant, I agree to use a condom
• 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 of surgery or major trauma within 12 weeks of screening and I do not plan to have surgery during the study
• I do not have a history of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or any history of drug abuse or addiction, within 12 months of screening
• I have not received a vaccination within 14 days prior to first dose
• I have not donated blood or blood products, or experienced significant blood loss, within 6 weeks of signing consent for this study
• I do not have a history of low blood sugar or gastroparesis.
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 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. 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.