Expired Study
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Clinical Trial 39488

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San Antonio, TX 78209


Study Summary:

ICON Early Phase Services is conducting a research study for overweight/obese adults ages 18-60. This study is being done to test a treatment for liver disease.  The study drugs will be given orally.    

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
  • 4 overnights (over 3 periods)
  • 12 dosing visits
  • 4 outpatient visits

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.  For more information, see below.


If you are able to answer “YES” to the following statements, you may qualify for this study.

 

  • I am an overweight/obese and otherwise healthy adult, meaning no significant medical conditions

 

  • I am between 18 and 60 years old

 

  • My BMI is between 25.0 and 40.0 kg/m2  (at screening)

 

  • I agree not to smoke while at the clinic and to abide by the rules of the clinic, which is a non-smoking facility

 

  • I have not used any experimental or investigational drug within 30 days prior to first dose

 

  • If Female, I am not pregnant or breastfeeding   

 

  • If Female and capable of becoming pregnant, I agree to use one acceptable  method of birth control during the study and for 30 days after completing the end of treatment.  Medically accepted methods of contraception for you and/or your partner will be defined in detail at screening.

 

  • If Female and of non-childbearing status, I am postmenopausal (for at least one year) and over age 55, or, less than 55 and able to confirm my status with a follicle-stimulating hormone test.  Or, I am surgically sterile (hysterectomy, ovaries removed and/or Fallopian tubes removed).  Medical records are required at screening. 

 

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

 

  • I am able to swallow pills

  

  • I do not have a history of drug/chemical or alcohol abuse within 3 months prior to screening and my alcohol consumption is less then 21 units/week (if male) or less than 14 units/week (if female)

 

  • I do not have clinically significant disease such as:
  • Autoimmune disease such as rheumatoid arthritis or systemic lupus erythematosus
  • Thrombophlebitis or deep vein thrombosis
  • Blood or coagulation disorders
  • Liver disease or dysfunction
  • Renal dysfunction or glomerular nephritis
  • Cancer (with the exception of treated basal cell carcinoma of the skin that has been cancer-free for 5 years, non-metastatic basal or squamous cell carcinoma of the skin, and cervical carcinoma in situ)
  • Clinically significant cardiovascular, gastrointestinal, pulmonary, endocrine, central nervous system (CNS) disorders or other major active and uncontrolled disease
  • Requirement for or intention to use systemic, chronic medications, herbal supplements, or over the counter medications during the study period.

 

  • I do not have uncontrolled hypothyroidism including thyroid-stimulating hormone

 

  • I have not donated blood, participated in multiple blood draws or a clinical study, had major trauma or surgery with/without blood loss within 30 days prior to first dose

 

  • I have not used any prescription or nonprescription drugs, vitamins, or dietary supplements within 14 days prior to first dose

 

  • I agree to abstain from vigorous (i.e., running) and strenuous (i.e., weight lifting) exercise during the study.  (NOTE: Walking at an accustomed pace is acceptable.)

 

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.  Frequently, subjects do not qualify because of medical history or minor changes in vital signs, ECG and lab tests.  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.  Additionally, 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 tobacco 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. 


Qualified Participants May Receive:

Qualified participants may be compensated up to $5,375 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.