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 being developed as an inhaled treatment for Pulmonary Arterial Hypertension.
The study will compare the safety and tolerability of 2 different oral inhalation doses.
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 visit
- Up to 29 consecutive overnights (Includes a holding period, meaning no procedures for up to 14 days) **
- Part 1 is Day -1 to Day 7
- Holding period is Day 8 to Day 21(no procedures and must be willing to stay in house)
- Part 2 is Day 22 to Day 29
- 1 Follow up phone call
** If the sponsor chooses not to run part 2 of the study, you will be paid $4800 in addition to $250/night stayed during the holding period. 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.
|Note: 1A will be filled before pts are placed in 1B||Cohort 1B|
|Part 1 Admit||May 10, 2021|
|Day 7||May 17|
|Holding period Day 8 to Day 20 (no procedures, must stay at unit)||May 18 to May 30|
|Part 2 Admit /Day 21 - patients already at unit||May 31|
|Follow-up Phone Call||Jun 14|
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 last visit–
- 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 while in this study, you must use highly effective birth control such as a condom and continue to use for 90 days after your last follow-up visit. You must also not donate sperm during the study and for 90 days after your last follow-up visit.
- I have suitable veins for multiple blood samples
- I am able to communicate effectively in English with the study personnel
- 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.
- GO 4623-0034
- Healthy Adults
- Male or Female
- Payment amount
- up to $9,600
- 18 - 55