ADDITIONAL STUDY INFORMATION

                 NOTE: Daily stool samples will be collected during this study.

                                       ___________________________________

Healthy MI 5082-0001

San Antonio - Texas

ICON Early Phase Services is conducting a research study for healthy adults ages 18-55. This study is being done to test a potential treatment to reduce itching due to liver disease.

Vital signs, ECGs, physical examinations and pregnancy, drug and alcohol screens will be performed. Blood and urine samples will also be obtained during this study as well as daily stool collections. 

Participants will complete:

  •  1 screening visit
  •  23 consecutive overnights
  •  1 outpatient visit

 

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 $8,250 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 55 (inclusive) years old at the time of screening.

 

  • My BMI is between 18.0 and 32.0 kg/m2.

 

  • I have not received any investigational drug/device administration within 30 days prior to first study drug administration or 5-half lives, whichever is longer.

 

  • If Female, I am not pregnant or breastfeeding   

 

  • If Female and capable of becoming pregnant, I agree to abstinence

     OR use of condoms PLUS one other acceptable form of contraception until 4   weeks after dosing with the study drug 

     OR have only same-sex partners, as my preferred and usual lifestyle.

 

     Methods of birth control include:

               Implantable progestogen-only hormone contraception

               Intrauterine device (IUD)

               Intrauterine hormone-releasing system (IUS)

               Bilateral tubal occlusion

               Vasectomized partner

              Combined (estrogen- and progesterone-containing) hormonal contraception (oral, intravaginal, transdermal, injectable)

              Progesterone-only hormonal contraceptives (oral, injectable)

              Heterosexual abstinence if this is the preferred and usual lifestyle

 

  • If Female and not capable of becoming pregnant, I have been postmenopausal for at least 12 months without an alternative medical cause OR  I am surgically sterile by 1 of the following: hysterectomy, bilateral salpingectomy, bilateral oophorectomy (uterus removed, tubes removed, ovaries removed) *documentation is needed 

OR I have permanent infertility due to an alternate medical cause (per PI discretion).   

 

  • If Male and I have a partner capable of becoming pregnant, I agree to use a condom for the duration of the study and until 12 weeks after dosing with the study drug

 

  • I am not smoker and have not used tobacco or nicotine-containing products within 30 days before the first dose through clinic discharge on Day 23. I agree 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

 

  • I have not donated blood or had significant blood loss within 30 days prior to screening

 

  • I have not donated plasma within 14 days prior to the first study drug administration

 

  • I have not used any prescription or over-the-counter medications, including herbal products and supplements recently. Use of hormonal contraception and acetaminophen is allowed.

 

  • I do not have a history or presence of any liver-related illness or diagnosis (such as inflammatory bowel disease, irritable bowel syndrome, Crohn’s disease)

 

  • I agree to donate blood and urine samples throughout the study as well as daily stool collections.

 

  • I do not have any history of significant drug-related allergic reactions, such as, anaphylaxis, Stevens-Johnson syndrome, urticarial or multiple drug allergies

 

  • I do not have a personal or family history of prolonged QT syndrome or family history of sudden death

 

  • I do not have an active infection

 

  • I have not had a recent history of alcoholism or drug/chemical abuse

 

  • I do not drink more than 14 servings of alcoholic beverages per week.

 

  • I am willing and able to consume standardized meals

 

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 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 MI 5082-0001

             ______________________________________________________

 

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

                Cohort 1

                            Admit: Nov 30, 2019 Sat - Discharge: Dec 23, 2019 Mon

                                Out-patient Visit: Dec 30, 2019 Mon

 

 

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 MI 5082-0001
Name
Details Healthy MI 5082-0001 - Not currently screening
Gender Male or Female
Dates -
Payment amount up to $8,250
Age 18 - 55

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