ICON Early Phase Services is conducting a research study for healthy adults ages 18-55. The purpose of this study is to evaluate the effect of multiple doses itraconazole on a single dose of an investigational study drug. Both drugs will be given as an oral solution.
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
- 14 consecutive overnights
- 1 outpatient visit
Length of study from admit to end of study is approximately 27 days.
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.
Qualified participants may be compensated up to $4,000 for time and travel.
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 female, meaning no significant medical conditions
- I am between 18 and 55 years old
- My BMI is between 18.0 and 30.0 kg/m2
- I am not currently participating or have not participated in a drug/device or biologic investigational research study within 3 months prior to dosing 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 salpingectomy or bilateral oophorectomy (documentation required)
- If Female and able to have children, I agree to use a highly effective method of contraception prior to the first dose of study drug, during the study and for at least 35 days after the last dose of study drug which include one of the following-
- Intrauterine device (non-hormonal)
- Bilateral tubal occlusion
- Sexual abstinence, defined as refraining from intercourse, when this is in line with the preferred and usual lifestyle of the subject.
- Documented sterile male partner
- If Male and my female partner can have children, I agree to use a condom and not donate sperm from the time of first dose, during the study and until follow up, in addition to having my female partner use one of the following forms of birth control - IUD (hormonal and non-hormonal), hormonal contraception (oral, intravaginal, transdermal).
- I have suitable veins for multiple blood samples
- 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 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.
If you are able to answer “YES” to the above questions and would like to make an appointment online please click on the following link:
STUDY DATES - Note: All dates and times are tentative and may change.
|Admit||Nov 06, 2020 Fri|
|Discharge||Nov 20, 2020 Fri|
|Outpatient Visit - End of Study||Dec 03, 2020 Thurs|
In order to schedule a screening appointment online, you will be required to enter your personal information (name, date of birth, etc.) into a secure, password protected database. Your information will remain confidential and will not be accessible by any party that does not work directly for ICON Early Phase Services. It may be necessary for the recruitment staff to contact you by phone in the event of a schedule change or if more information is needed. You have the right to remove your information from the database at any time by logging in to the scheduling program and choosing “My Profile” and then selecting the “Terminate Account” button.
PURSUANT TO SECTION 30.06,
PENAL CODE (TRESPASS BY HOLDER OF A LICENSE TO CARRY A CONCEALED HANDGUN)
A PERSON LICENSED UNDER SUBCHAPTER H, CHAPTER 411, GOVERNMENT CODE (CONCEALED HANDGUN LAW), MAY NOT ENTER THIS PROPERTY WITH A CONCEALED HANDGUN.
- GA 3561-0016
- GA 3561-0016
- Healthy Adults - New dates coming!
- Male or Female
- Payment amount
- up to $4,000
- 18 - 55