ICON Early Phase Services is conducting a research study for healthy non-smoking adults ages 18-55. The purpose of this study is to evaluate the safety and tolerability of an investigational drug when given with and without other medications.  The study drug is being developed as an inhaled treatment for Pulmonary Arterial Hypertension.

CLICK HERE to make an appointment for GO 4623-0035

Or call 210-225-5437 for more information

Vital signs, ECGs, physical examinations, drug (to include marijuana), tobacco and alcohol testing will be performed. Blood, Nasopharyngeal and urine samples will also be obtained during this study.  Your lung function will also be assessed.

  • Participants will complete:
  • Screening visits
  • Up to 29 consecutive overnights (Includes a holding period, meaning no procedures for up to 14 days)
  • 1 Follow up phone call (approximately Day 37)

To determine if you fully qualify, it will be necessary to obtain blood samples after an 10- hour fast.  You have the option of fasting for the screening appointment, or, you may return at a later date.   For more information, see below.

Qualified participants may be compensated up to $9,600 for time and travel.

Study Dates - Please note dates are subject to change.

Partial payment available. Cohort 1A Cohort 1B
Admit June 26, 2021 Sat June 27, 2021 Sunday
* Day 15 - payment made within 10 business days July 11 July 12
Discharge July 25, 2021 Sun July 26, 2021 Monday
Follow up phone call - payment made within 10 buisness days Aug 01, 2021 Sun Aug. 02, 2021 Monday

 

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

  • I am a healthy non-smoking male or female meaning no significant medical conditions
  • I am between 18 and 55 years old
  • My BMI is  between 18.0 and 32.0 kg/m2   and my weight is at least 110 pounds
  • I have not taken an investigational drug or participated in any clinical study  within 30 days prior to dosing or currently participating in another clinical study.
  • My GFR is greater than 80 mL/Min
  • If Female, I meet one of the following: 
    • Postmenopausal (no menses for 12 months)
    • Surgically sterile
    • Child bearing and agree to use from screening until for 90 days  after the study dischage–
  • Acceptable methods are:
    • Intrauterine device (IUD)
    • Intrauterine system
    • Contraceptive Implant
    • Combined injectable contraceptives
    • Hormonal oral contraceptives when used in combination with male condoms with spermicide
    • Sexual abstinence if it is the preferred and usual lifestyle.
    • If a female subject confirms that her male partner(s) has been confirmed to be clinically sterile (ie, documented infertility or surgical sterilization; see below for additional information on sterility), this method is acceptable as the only means of contraception
  • If Male, and choose to have sex with women of childbearing potential  while in this study, you must use highly effective birth control such as a condom and continue to use for 90 days after study  discharge. You must also not donate sperm during the study and for 90 days after study discharge.
  • I have suitable veins for multiple blood samples
  • I am able to communicate effectively in English with the study personnel

Screening Reminders -

  • 10 hours fasting is required for lab work (only water is allowed)
  • If taking medications, bring them to your screening appointment.
  • 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.
  •  Arrive 30 minutes before your appointment to complete paper work.
Reference
GO 4623-0035
Name
GO 4623-0035
Details
Healthy Adults - Currently Screening Males and Non-childbearing Females Only.
Gender
Male or Female
Payment amount
up to $9,600
Age
18 - 55