Healthy GL 3507-0037

San Antonio - Texas

ICON Early Phase Services is conducting a research study for healthy adults ages 18-60. This study is being done to test a new formulation of a drug in development as a potential treatment for sickle cell anemia.

Vital signs, ECGs, physical examinations and pregnancy, drug, alcohol and tobacco usage/nicotine screens will be performed. Blood and urine samples will also be obtained during this study. 

Participants will complete:

  •  1 screening visit
  •  10 overnights over 2 periods
  •  5 outpatient visits

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.

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 adult, meaning no significant medical conditions

 

  • I am between 18 and 60 (inclusive) years old

 

  • My BMI is between 18.0 and 30.0 kg/m2 (inclusive) and I weigh at least 110 lbs.

 

  • I have not participated in any investigational drug (or medical device) clinical trial within 30 days or 5 half-lives prior to screening. *Whichever is longer.  I am not currently participating in another trial of an investigational drug (or medical device). 

 

  • I do not use tobacco or nicotine-containing products (e.g., cigarettes, cigars, chewing tobacco, snuff, nicotine patches, electronic cigarettes).  I agree not to use these products for the duration of the study and to abide by the rules of the clinic, which is a non-smoking facility. 

 

  • If Female, I am not pregnant or breastfeeding   

 

  • If Female and not capable of becoming pregnant, I have been postmenopausal for at least 2 years or I am surgically sterile (uterus removed, tubes tied, ovaries removed)

 

  • If Male and I have a partner capable of becoming pregnant, I agree to use a highly effective method of birth control during the study and for 3 months following the last dose.  Highly effective methods of birth control are:
  • condom + diaphragm
  • condom + spermicide
  • diaphragm + spermicide
  • intrauterine device
  • oral/injectable/implanted hormonal contraceptives used in combination with an additional double-barrier method
  • sexual abstinence

 

  • If Male, I agree to not donate sperm during the study and for 3 months following last dose   

 

  • I am able to communicate effectively in English with the study personnel

 

  • I do not have clinically significant allergies (seasonal allergies are acceptable) or disease

 

  • I have not had surgery to remove parts of my stomach, bowel, liver, gall bladder or pancreas

 

  • I have not recently had surgery or major trauma and I do not plan to have surgery planned during the study 

 

  • I am currently healthy and I do not have any signs/symptoms of acute illness

 

  • I have not recently used prescription medications, over-the-counter (OTC) drugs (including herbal preparations or dietary supplements), or drugs that require continuing use during study participation

 

  • I do not have a high consumption of caffeine and I can abstain from consuming caffeine or xanthine-containing products (e.g., tea, coffee, chocolate, cola) as required by the study

 

  • I am able to abstain from consuming alcohol, grapefruit/grapefruit juice and from strenuous exercise (such as weight training or aerobics) as required by the study

 

  • I have not recently experienced significant blood loss or donated blood or blood products

 

  • I have good venous access.   

 

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 tobacco use and 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.  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 3507-0037

                              *Compensation in multiple payments.

                              ___________________________________

 

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

 

                   Cohort 1

                         First Admit: Nov 20, 2019 Wed  -  Discharge: Nov 25, 2019 Mon

                               Out-patient Visits: Dec 02 Mon, Dec 10 Tue

                         Second Admit: Dec 18, 2019 Wed  -  Discharge: Dec 23, 2019 Mon

                               Out-patient Visits: Dec 30 Mon, Jan 07, 2020 Tue

                                End of Study Visit: Jan 16, 2020 Thurs

 

 

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 3507-0037
Name
Details Healthy GL 3507-0037 - Females must be postmenopausal or surgically sterile with documentation. Compensation in multiple payments. - Now screening
Gender Male or Female
Dates -
Payment amount up to $5,500
Age 18 - 60

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