ADDITIONAL INFORMATION - 

         - Postmenopausal females are allowed for this study, if it has been longer than one year since their last menses.

         - Females with hysterectomies and oopherectomies are allowed for this study.  You must bring documentation to your screening appointment.

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Healthy CL 3998-0005 FE

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 for connective tissue and bone 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
  •  9 overnights (over 3 periods)

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.

 

Qualified participants may be compensated up to $4,150 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

 

  • My BMI is between 18.0 and 30.0 kg/m2 and I weigh at least 110 lbs.  (NOTE: Enter your height and weight into the BMI calculator at the top of the page.)

 

  • 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 have not received any investigational drug or experimental procedure in a clinical trial within 30 days prior to first dose

 

  • If Female, I am not pregnant or breastfeeding.  I do not plan to donate eggs for in vitro fertilization while on study and for 30 days after last visit

 

  • If Female and capable of becoming pregnant, I agree to either remain abstinent from heterosexual sex during dosing and for 1 month after dosing, or, if sexually active, to use (2) effective methods of birth control at least one month before dosing, during dosing and for 1 month after dosing.  Acceptable methods of birth control are as follows:

 

Highly effective methods of birth control:

  • Established use of oral, transdermal, or intravaginal combined (estrogen and progesterone containing) hormonal method of contraception.
  • Established use of oral (excluding mini-progesterone-only pill), injectable, or implantable progesterone-only hormonal contraception.
  • Placement of an intrauterine device (IUD) or intrauterine system (IUS).
  • Male sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate).  For female subjects on the study, the vasectomized male partner should be the sole partner for that subject.
  • Bilateral tubal occlusion.

 

NOTE: Two hormonal forms cannot be used together. Females who are taking oral contraceptives must be on a stable dose for 3 months before dosing is to start and remain on the same dose throughout the study.

 

Other effective methods of birth control include the following:

  • Barrier forms (always used with spermicide) – diaphragm, cervical cap
  • Barrier forms (used with or without spermicide) – male latex condom
  • Others – vaginal sponge (contains spermicide)

 

The following are unacceptable forms of birth control:

  • Progestin only “mini-pill”
  • Female condom
  • Natural family planning (periodic abstinence, such as calendar, ovulation, symptothermal, post-ovulation methods; rhythm method; or breastfeeding) or withdrawal 

 

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

 

  • If Male and I have a partner capable of becoming pregnant, I agree to remain abstinent from heterosexual sex during dosing and for 1 month after dosing.  If sexually active, I agree to use effective methods of birth control, one of which must be highly effective. 

 

  • If Male and I have a partner capable of becoming pregnant, my partner must be willing to use a form of contraception as described above

 

  • If Male, I agree not to donate sperm for 30 days after last visit

 

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

 

  • I am able to consume a standardized high-fat meal and I am able to consume applesauce.  There are no substitutions allowed for the meal.

 

  • I do not have a history or current evidence of a clinically significant or uncontrolled disease

 

  • I have not had any type of gastric bypass or had my gallbladder removed

 

  • I do not have a history of allergies or hypersensitivity to drugs, gelatin, lactose or cherries

 

  • I have not have a history of alcohol and/or substance abuse

 

  • I have not been hospitalized for a significant medical disorder in the recent past

 

 

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.  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 alcohol 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, or passport.  Also, be advised that we cannot accept a military ID as we are legally prohibited from copying that form of identification for our records. *Note: As of Nov. 01, 2018 our policy has changed and MILITARY IDs ARE NOW ALLOWED.  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 CL 3998-0005 FE

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

      Cohort 1

           First Admit: Jan 29, 2019 (11:00AM) - Discharge: Feb 01, 2019

           Second Admit: Feb 03, 2019  - Discharge: Feb 06, 2019

           Third Admit: Feb 08, 2019  - Discharge: Feb 11, 2019

 

 

Reference CL 3998-0005 FE
Name
Details Healthy CL 3998-0005 FE
Gender Male or Female
Dates -
Payment amount up to $4,150
Age 18 - 55

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