Expired Study
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Clinical Trial 42396

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 new formulation of a treatment for chronic inflammatory conditions including autoimmune disorders.

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
  •  7 consecutive overnights
  •  1 follow-up phone call

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 BMI  ≥ 18 and ≤ 33 kg/m2

 

  • I have not received any investigational drug in a clinical trial within 30 days prior to first dose or 5-half lives of the drug (whichever was longer)

 

  • 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 for at least 28 days prior to dosing, during the study and for a period of 28 days after last dose.  Your chosen form of contraception must be effective by the time of randomization.  Methods of birth control include two options: 

 

Option 1: One highly effective method (e.g., hormonal contraception [oral, injection, implant, transdermal patch, vaginal ring]; intrauterine device; tubal ligation; or partner’s vasectomy) AND 1 additional form (latex condom or any non-latex condom not made of natural [animal] membrane [e.g., polyurethane], diaphragm, sponge).

 

Option 2:  Male or female condom (latex condom or non-latex condom NOT made out of natural [animal] membrane [for example, polyurethane) PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide

 

  • If Female and not capable of becoming pregnant, I have been postmenopausal for at least 24 months or I am surgically sterile (uterus removed, ovaries removed) *Must have documentation at screening.

 

  • If Female, I agree to refrain from donating ova while participating in this study and for 90 days after last dose

 

  • If Male, I will practice true abstinence (which must be reviewed on a monthly basis and source documented), or, I agree to use a barrier method of birth control (condoms not made out of natural [animal] membrane [latex condoms are recommended]) during sexual contact with a pregnant female or a female of childbearing potential for the duration of the study and for at least 28 days after the dose 

 

  • If Male, I agree to refrain from donating sperm while participating in this study and for 90 days after last dose

 

  • I have not used any moderate or strong CYP3A4/5 inducers and/or inhibitors (including St. John’s wort) within 30 days prior to dosing

 

  • 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 do not have any significant medical conditions

 

  • I have not had any surgical procedures or have a medical condition that could possibly affect drug metabolism (no bariatric procedures).  NOTE: A subject with appendectomy and/or cholecystectomy may be included.

 

  • I have not recently donated blood or blood products and agree not to donate for 28 after the last study dose

 

  •  I do not have a recent history of drug abuse 

 

  •  I do not have a recent history of alcohol abuse

 

  • I have not recently received a live vaccination (excluding seasonal flu vaccination) and agree not to receive one for 30 days prior to first dose

 

  • I have not recently used a systemic or topic medication

 

  • I have not recently used over-the-counter systemic/topical medications (including vitamin/mineral supplements, herbal medicines such as St. John’s Wort)

 

  • I agree to refrain from strenuous physical activity or contact sports as required

 

  • I agree to avoid consumption of coffee, tea or other caffeine-containing products as required

 

  • I agree to avoid consumption of alcohol and any alcohol-containing products  for 48 hours prior to screening and 48 hours prior to admission to the unit

 

  • I agree to avoid consumption of Seville oranges, grapefruit or grapefruit juice and/or pomelos, exotic citrus fruits, or grapefruit hybrids for 14 days prior to first dose and throughout 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 drug abuse.  Please refrain from consuming alcohol at least 48 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 $3,000 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.