ICON Early Phase Services is conducting a research study for healthy adults ages 18-65. The purpose of this study is to measure the effect of a single dose of an investigational medication (given orally) given under fasting conditions.
Clinical trial study for healthy adults ages 18-65
Vital signs, ECGs, physical examinations, pregnancy and drug testing will be performed. Blood and urine samples will also be obtained during this study.
Participants will complete:
• 1 screening visit
• 4 consecutive overnights
• 1 follow up phone call
Length of study from admit to end of study is 7 days.
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 non-smoking adult, meaning no significant medical conditions
• My BMI is between 19.0 and 29.0 kg/m2 and my body weight is greater than or equal to 110 pounds
• I have not participated in an investigational study of a drug or device within 3 months prior to dosing for this study
• If Female, I am not pregnant or breastfeeding and if able to have children, agree to use an acceptable form of contraception from screening until the end of the study such as IUD(progesterone only) combined with diaphragm, cervical cap or condom.
• If female and not able to have children, I am naturally postmenopausal or surgically sterile(bilateral oophorectomy, hysterectomy or tubal ligation).
• If male, I do not have a female partner who is currently pregnant or wanting to become pregnant.
• If male and sexually active, I agree to be abstinent or use highly effective APPROVED method of contraception during heterosexual intercourse; or If male with a vasectomy, I agree to use a condom.
• I do not have any food allergies or dietary restrictions (e.g. vegetarian, dairy)
• I am non 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
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.
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 drugs of abuse, tobacco and alcohol.
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.
Name of Clinical Site
8307 Gault Lane, San Antonio, TX, USA