ICON Early Phase Services is conducting a research study for healthy females age 18 and over. This study is being done to determine if nausea occurs when the study drug is given.
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
- 1 outpatient visit
- 1 follow-up phone call
To determine if you fully qualify, it will be necessary to obtain blood samples after a 10- 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 female adult, meaning no significant medical conditions
- I am between 18 and 55 years old
- 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 experimental procedure in a clinical trial within 30 days prior to dose
- I am not pregnant or breastfeeding
- If capable of bearing children and sexually active with a non-sterilized male partner, I agree to use stable contraception throughout the study. Contraception must be used for at least 3 months prior to screening and for 30 days after last dose. In the case where a single barrier method has been used for 3 months prior to Screening, a second barrier method may be added starting at Visit 1.
Acceptable methods of contraception for this study include:
- Surgical sterilization of the subject (for at least 6 months) or male partner (NOTE: Medical records are required.)
- Food and Drug Administration/FDA-approved female hormonal contraceptives
- IUD
- Essure (transcervical sterilization)
- “Double-barrier” contraception defined as:
- condom + spermicide, or
- condom + diaphragm (which is used with a spermicide)
- I am able to communicate effectively in English with the study personnel
- I have not had any gastrointestinal disease or surgery
- I do not have uncontrolled high blood pressure
- I do not have a history or presence of cancer within the past 5 years, with the exception of treated localized skin cancer (basal cell or squamous cell carcinoma)
- I do not have significant allergies including drug allergies and anaphylactic reaction
- I have not donated blood within 30 days prior to screening
- I have not had an acute illness within 30 days prior to screening
- I do not have a history of alcohol abuse or drug abuse in the last 12 months
- I agree to maintain my normal diet from screening to the end of the study
- I agree to abstain from taking any over-the-counter medications, nutritional or dietary supplements, herbal preparations or vitamins prior to dose and through the end of the study
- I agree to abstain from taking any prescription medications for 7 days prior to the dose and 1 day after dose (NOTE: FDA-approved hormonal contraception is allowed.)
- I agree to avoid strenuous exercise (48 hrs prior to dose), sun bathing/sun exposure/tanning (3 days prior to the dose and 1 day after dose).
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 a 10-hour fast. You have the option of fasting for a blood or urine sample at the screening appointment, or, you may return a day later for us to obtain these samples.
If you fast, you should refrain from eating or drinking anything (with the exception of water) for 10 hours before your appointment. We will be testing for 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, 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 admit to the study. Note that full medical records include surgical reports.