ICON Early Phase Services is conducting a research study of an investigational medication for healthy adults ages 18-45, and also adults age 65+, in separate cohorts. This study is being done to test an investigational medication in the potential treatment for a variety of mood and movement disorders (including major depressive disorder, postpartum depression, bipolar depression, essential tremor and Parkinson’s disease).
Vital signs, ECGs, physical examinations and pregnancy and drug and alcohol screens will be performed. Blood and urine samples will also be obtained during this study.
Participants will complete:
- 1 screening visit
- 9 consecutive overnights
- follow-up phone call
If you are able to answer “YES” to all of the following statements, you may be eligible to participate in this study.
- I am a healthy adult, meaning no significant medical conditions
- I am between 18 and 45 (inclusive) years old, or, I am age 65+ (inclusive)
- My BMI is between 18.0 and 35.0 kg/m2 (inclusive) and I weigh at least 110 lbs.
- I have not received any investigational medication or device within 30 days prior to screening
- If Female, I am not pregnant or breastfeeding
- If Female and capable of becoming pregnant, I agree to use at least one method of highly effective contraception while on study and for 30 days following the last dose. Acceptable forms of highly effective contraception for participants of childbearing potential, or, for partners of male participants who are of childbearing potential include:
- Combined (estrogen and progestogen containing) oral, intravaginal, or transdermal hormonal contraception associated with inhibition of ovulation
- Oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation
- Intrauterine device
- Intrauterine hormone-releasing system
- Bilateral tubal ligation or bilateral tubal occlusion (performed at least 3 months prior to screening)
- Vasectomized partner (performed at least 3 months prior to screening)
- Sexual abstinence (no sexual intercourse)
- If Female and not capable of becoming pregnant, I have been postmenopausal for at least 12 months or I am surgically sterile (ovaries removed, uterus removed, tubes removed). Or, I do not engage in sexual relations which carry a risk of pregnancy (does not include abstinence).
- If Male, I agree to use an acceptable method of effective contraception for the duration of the study and for 5 days after receiving the last dose. Or, I do not engage in sexual relation(s) which carry a risk of pregnancy. Acceptable forms of contraception include:
- Sexual abstinence (no sexual intercourse)
- History of vasectomy (performed at least 3 months prior to screening)
- Condom with spermicide used together with highly effective female contraceptive methods if the female partner(s) is of childbearing potential (see above for list of acceptable female contraceptive methods)
- If Male, I am willing to abstain from sperm donation during the study and for 5 days after last dose
- I am not a smoker and 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 am able to communicate effectively in English with the study personnel
- I do not have a history or presence of psychiatric or neurologic disease or condition
- I have not recently donated blood or experienced acute loss of blood
- I have not had significant gastrointestinal disease and/or surgery (e.g., gastrectomy or gastric bypass)
- I do not have a recent history of suicidal behavior
- I do not have a recent history of alcoholism or drug/chemical abuse
- I have not recently consumed grapefruit juice, grapefruit, Seville oranges or products containing these food items
- I have not recently consumed excessive amounts of caffeine products (i.e., coffee, tea, cola, other caffeinated beverages)
- I have not recently taken any prescription, over-the-counter or herbal medications. Hormonal contraceptives, vitamins and/or mineral supplements, and over-the-counter analgesics are allowed. (NOTE: Medications prescribed for well‑controlled chronic diseases at stable doses -- no dose change for 6 weeks prior to Admission -- are allowed for elderly participants at the discretion of the Investigator.)
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 be eligible for that study. Additionally, subjects are screened on a first come-first served basis and studies may complete enrollment prior to your visit.
No guarantees can be made regarding group assignments for any particular study. ICON will not assume any liability for lost time, travel or ineligibility.
To determine if you are eligible, 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 screening 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 appointment. We accept a government issued identification card such as a driver's license, state issued ID card, military ID or passport. 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 be admitted to the study. Note that full medical records include surgical reports.