ICON Early Phase Services is conducting a research study for healthy non-smoking males and females ages 18-55. The purpose of this study is to test the safety and tolerability of an investigational study drug. The study drug is being developed for sickle cell disease and will be given orally.
Clinical trial study for healthy non-smoking males and females ages 18-55 – GL 3507-0059
Vital signs, ECGs, physical examinations, drug, tobacco and alcohol testing will be performed as part of the study. Blood, nasopharyngeal and urine samples will also be obtained during this study.
Participants will complete:
21 Consecutive overnights
8 Outpatient visits (End of Study is Day 99)
To determine if you fully qualify, it will be necessary to obtain blood samples after an 8- hour fast. You have the option of fasting for the screening appointment, or, you may return later. For more information, see below.
Qualified participants may be compensated up to $15,480 for time and travel. Partial stipend payment available.
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 (non-childbearing), meaning no significant medical conditions
I am between 18 and 55 years old
My BMI is between 18.0 and 30.0 kg/m2 and I weigh at least 110 pounds
I have not received treatment with an investigational drug within 30 days (or 5 half-lives) prior to screening or currently participating in another trial of an investigational drug or medical device
If Female, I am non-childbearing and meet one of the following criteria- postmenopausal or surgically sterile (bilateral tubal ligation, bilateral salpingectomy, bilateral oophorectomy and/or hysterectomy) – Documentation required.
If Male, I agree to refrain from sperm donation and use an effective method of contraception (with partner of childbearing potential) for the duration of the study and for 120 days after the last dose of study drug such as
Male condom with spermicide used with highly effective female contraceptive method ( IUD, intrauterine system or hormonal method of contraception such as oral, injected, implanted, or transdermal)
Sexual abstinence (no sexual intercourse)
I have suitable veins for multiple blood samples
I am able to communicate effectively in English with the study personnel
Screening Reminders –
8 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.
Name of Clinical Site
ICON Early Phase Services, LLC, Gault Lane, San Antonio, TX, USA