Last updated on December 2018

Healthy RE 3957-0002 SAD

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Abnormal Blood Vessels (Arteriovenous Malformations) | Healthy Patient Studies | *Healthy Patient Studies
  • Age: Between 18 - 50 Years
  • Gender: Male or Female

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 50 (inclusive) years old.
  • My BMI is between 18.0 and 35.0 kg/m² (inclusive) and I do not weigh more than 291 lbs.
  • I have not smoked cigarettes recently. 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 product within the last 3 months and I am not currently enrolled in a clinical trial involving an investigational product.
  • If Female, I am not pregnant or breastfeeding. I do not intend to become pregnant while on study.     
  • If Female and capable of becoming pregnant, I agree to use 2 highly effective methods of birth control during the study and for at least 60 days after last dose.  Methods of birth control include:
    • Combined (estrogen and progesterone containing) hormonal contraception (oral, intravaginal, transdermal)
    • Progesterone-only hormonal contraceptives (oral, injectable)
    • Condom plus spermicide
    • Vasectomized partner
    • Implantable progestogen only hormonal contraception (IUD, intrauterine hormone-releasing system)
    • Bilateral tubal occlusion
    • Heterosexual abstinence if this is the preferred and usual lifestyle
  • If Female and not capable of becoming pregnant, I have been postmenopausal and without menses for at least 1 year or I am surgically sterile (uterus removed, tubes removed, tubes tied, ovaries removed).
  • If Male and I have a partner capable of becoming pregnant, I agree to use acceptable contraception during the treatment period and for at least 60 days after the last dose. Acceptable methods of contraception include abstinence, use of a male condom and another contraceptive method used by my female partner.  Acceptable methods for females are listed above. 
  • If Male and my partner is pregnant or breastfeeding, I agree to remain abstinent from intercourse or use a condom.
  • I am able to communicate effectively in English with the study personnel.
  • I have not recently used multivitamins/vitamins, herbal supplements, aspirin, diuretics, or other prescription or over-the-counter medications. Please note that Paracetamol, oral NSAIDs, thyroid treatment, oral contraceptives, and estrogen replacement therapy are permitted. Some OTC medications may also be allowed as deemed acceptable by the investigator. 
  • I do not have a history of any clinically relevant disease or disorder.
  • I do not use drugs of abuse.
  • I have not recently donated blood.
  • My average weekly alcohol usage does not exceed 21 units/week for males or 14 units/week for females.
  • I do not have a history of alcohol abuse within the previous 12 months.
  • I have good venous access to allow for blood sampling.

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.  We 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.

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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