Clinical Trial 43583

San Antonio, TX 78209


Summary:

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 for rare cholestatic liver diseases including Alagille Syndrome (ALGS).  The study drug will be administered orally. 
 

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

Participants will complete:

  •  1 screening visit
  •  9 consecutive overnights

 

To determine if you fully qualify, it will be necessary to obtain blood samples after a  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.



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

 

  • My BMI is between 18.0 and 32.0 kg/m2 (inclusive)

 

  • I have not had an investigational drug or device within 30 days (or 5 half-lives whichever is longer) prior to first dose

 

  • 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 1 week after dosing with study treatment:

    • intrauterine device

    • hormonal contraception

    • female diaphragm

    • same-sex partners (this is my preferred and usual lifestyle)

  • If Female and not capable of becoming pregnant, I have been postmenopausal for at least 1 year or I am surgically sterile (tubes blocked, tubes tied, tubes removed, uterus removed, ovaries removed)   

 

  • 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 7 days post dose

 

  • I am not a 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

     

  • I do not have a history or presence of liver related illness or disease

     

  • I do not have a history of any significant drug-related allergic reactions

     

  • I have not recently had surgery

     

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

     

  • I do not have an active infection

     

  • I have not had a recent acute illness

     

  • I have not recently used any prescription or over-the-counter medications (including herbal products and supplements).NOTE: Hormonal contraception and a daily dose (≤ 2g per day) of acetaminophen is allowed.

     

  • I do not have a recent history or presence of alcoholism or drug abuse

     

  • I do not consume more than 14 units of alcohol per week

     

  • I have not recently donated blood or plasma

     

  • I have not recently experienced a significant blood loss

     

  • I am able to consume high-fat meals and standardized meals as required by the study

     

  • I am able to avoid consuming foods and beverages as required by the study

     

  • I am able to avoid consuming caffeine-containing foods and beverages as required by the study (e.g., coffee, tea, cola drinks chocolate)

     

  • I am able to refrain from strenuous exercise as required by the study.

     

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 a 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 alcohol, drug abuse and tobacco use.  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. 


Qualified Participants May Receive:

Qualified participants may be compensated up to $3,850 for time and travel.


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.