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.
Clinical trial study GO 4623-0035
The study drug is being developed as an inhaled treatment for Pulmonary Arterial Hypertension.
Participants will complete:
•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)
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.
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.
Study Dates – Please note dates are subject to change.
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)
-Child bearing and agree to use from screening until for 90 days after the study dischage–
•Acceptable methods are:
-Intrauterine device (IUD)
-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
Name of Clinical Site
8307 Gault Lane, San Antonio, TX, USA