Updated on Oct 22, 2020 - The $200 Refer A Friend applies to subjects that dose for the study. They do NOT have to be new to our database or subjects that have never dosed at ICON.

* There is a partial payment after the first period.

San Antonio - Texas

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.

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

Length of study from admit to end of study is 57 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 $5,500 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 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. 

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:

 

Click here to make an appointment for GL 3507-0049

 

*Compensation partial payment after period 1.

 

STUDY DATES - Note: All dates and times are tentative and may change.

Cohort 2

Period 1  
Admit Nov 03, 2020 Tue
Discharge Nov 08, 2020 Sun
Outpatient Nov 15, 2020 Sun
Outpatient Nov 23, 2020 Mon
Period 2  
Admit Dec 01, 2020 Tue
Discharge Dec 06, 2020 Sun
Outpatient Dec 13, 2020 Sun
Outpatient Dec 21, 2020 Mon
Outpatient - end of study Dec 30, 2020 Wed

 
 

Notice:

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.

Reference
GL 3507-0049
Name
GL 3507-0049
Details
Healthy Adults - Study Updated - New Criteria! You may be eligible for Rescreening - Schedule an appointment! $200 Refer A Friend applies to subjects that dose - they do NOT have to be new to our database. Partial payment after period 1!
Gender
Male or Female
Payment amount
up to $5,500
Age
18 - 60