ICON Early Phase Services is conducting a research study for healthy adults ages 18-60. The purpose of this study is to measure the effect of a single dose of an FDA approved drug(oral suspension formulation) is equal to the single dose (dispersible tablet formulation) of the same drug in healthy fasted subjects.
Clinical trial study for healthy adults ages 18-60
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
•10 overnights (2 periods of 5 overnights)
•5 outpatient visits
To determine if you fully qualify, it will be necessary to obtain blood samples after an 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 non-smoking male or non-childbearing female, meaning no significant medical conditions
•I am between 18 and 60 years old
•My BMI is between 18.0 and 30.0 kg/m2 and my body weight is greater than or equal to 110 pounds
•I have not participated in a clinical trial of an investigational drug or device within 30 days prior to screening for this study
•My renal function tests (GFR) are greater than 80 mL/Min
•If Female, I am postmenopausal or surgically sterile by hysterectomy, bilateral tubal ligation or bilateral oophorectomy (documentation required)
•If Male and my female partner can have children, I agree to use a highly effective method of birth control and agree to not donate sperm for the duration of the study and 3 months following discharge the last dose of study drug
•I have suitable veins for multiple blood samples
•I am not 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 10-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 10-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.
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. You will not be allowed to participate in the study without medical records defined as:
All medical records, including but not limited to: office notes, face sheets, history and physical, consultation notes, inpatient, outpatient and emergency room treatment, all clinical charts, reports, surgical reports, order sheets, progress notes, nurse’s notes, social worker records, clinic records, treatment plans, admission records, discharge summaries, reports of consultations, documents, correspondence, test results, statements, questionnaires/histories, from your medical provider(s).
For females, surgical reports are required as documentation for procedures such as hysterectomy, bilateral oophorectomy and tubal ligation.
Name of Clinical Site
8307 Gault Lane, San Antonio, TX, USA