Expired Study
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Clinical Trial 42590

San Antonio, TX 78209


Study 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 multiple sclerosis, and inflammatory bowel disease (including ulcerative colitis and Crohn’s 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.

 

Participants will complete:

  •  1 screening visit
  •  15 consecutive overnights
  •  1 follow-up phone call

 

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.



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 30.0 kg/m2 (inclusive) and I weigh at least 110 lbs.

 

  • I have not received any investigational drug within 30 days (or 5 times the half-life) prior to first dose

 

  • I do not use tobacco or nicotine-containing products (including but not limited to cigarettes, pipes, cigars, electronic cigarettes, vape, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) or marijuana (cigarette, joint, vape, edibles, etc.).  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

 

  • If Female, I am not pregnant or breastfeeding   

 

  • If Female and capable of becoming pregnant, I agree to use a highly effective method of birth control during the study and until completion of the follow-up phone call.  Methods of birth control include: 
    • Combined hormonal (estrogen and progestogen containing) contraception, which may be oral, intravaginal, or transdermal
    • Progestogen-only hormonal contraception associated with inhibition of ovulation, which may be oral, injectable, implantable
    • Placement of an intrauterine device or intrauterine hormone-releasing system
    • Bilateral tubal occlusion
    • Vasectomized partner
    • Sexual abstinence

NOTE: Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea method are not acceptable methods of contraception. Female condom and male condom should not be used together.

 

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

 

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

 

  • I have not recently used any systemic over-the-counter medication (excluding acetaminophen up to 1 g/day), dietary or herbal supplement (excluding vitamins/multivitamins) or herbal supplements including St. John’s wort

 

  • I have not recently used any systemic prescription medication (excluding hormonal contraceptives)

 

  • I am willing and able to follow the restrictions on alcohol consumption, strenuous physical activities as required by the study

 

  • I have not recently donated blood

 

  • 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. 


Qualified Participants May Receive:

Qualified participants may be compensated up to $5,600 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.