ICON Early Phase Services is conducting a research study for healthy adults ages 18-55. This study is being done to test a potential treatment for sickle cell disease.
Vital signs, ECGs, physical examinations and pregnancy, drug and alcohol screens will be performed. Blood and urine samples will also be obtained during this study.
Participants will complete:
- 1 screening visit
- 19 overnights (2 periods)
- 1 outpatient visit
To determine if you fully qualify, it will be necessary to obtain blood samples after a 10- hour fast. You have the option of fasting for the screening appointment, or, you may return at a later date. If ICON does not have your medical records on file, you will need to provide medical records at screening.
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 55 (inclusive) years old
- My BMI is between 18.0 and 30.0 kg/m2 (inclusive) and I weigh at least 110 lbs.
- I am a nonsmoker and I have not recently used any tobacco or nicotine‑containing products (e.g., cigarettes, cigars, chewing tobacco, snuff, nicotine patches, and electronic cigarettes). I agree not to use any of these products for the duration of the study and to abide by the rules of the clinic, which is a non-smoking facility.
- I have not participated in another clinical trial of an investigational drug (or medical device) within 30 days prior to screening, and, I am not currently participating in a similar clinical trial
- If Female, I am not capable of becoming pregnant. I have been postmenopausal for at least 2 years or I am surgically sterile (uterus removed, tubes tied, ovaries removed). Documentation is required.
- If Male and I have a partner capable of becoming pregnant, I agree to use a highly effective method of birth control during the study and for 30 days following last dose. A highly effective method of birth control is defined as:
- condom + diaphragm
- condom + spermicide
- diaphragm + spermicide
- intrauterine device
- oral/injectable/implanted hormonal contraceptives used in combination with an additional double-barrier method
- sexual abstinence
- If Male, I agree not to donate sperm
- I am able to communicate effectively in English with the study personnel
- I do not have a history or presence of clinically significant allergic diseases (except for untreated, asymptomatic, seasonal allergies)
- I have not had previous gastrointestinal surgery (including removal of parts of the stomach, bowel, liver, or pancreas). NOTE: Gallbladder removal or an appendectomy are allowed.
- I do not have a recent history of surgery or major trauma and I do not plan to have surgery during the study
- I do not have a history of heart problems, or a family history of long QT syndrome or sudden death
- I do not have a history of alcohol abuse, illicit drug use, significant mental illness, or physical dependence to any opioid
- I have not recently used any prescription medications, over the counter drugs, herbal preparations or dietary supplements
- I do not have a high consumption of caffeine and I am willing to abstain from consuming caffeine and xanthine-containing products while on study
- I have not recently consumed grapefruit and/or grapefruit juice and I am willing to abstain from these products until the end of the study
- I am willing to abstain from strenuous physical exercise (such as weight training or aerobics) prior to first dose through the end of the study
- I agree not to eat black licorice while on study
- I have not recently had a significant blood loss, or donated blood, or blood components
- I am able to consume standardized meals with no substitutions
- I have good venous access.
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. ICON 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 a 10-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.
If you fast, you should refrain from eating or drinking anything (with the exception of water) for 10 hours before your appointment. We will be testing for tobacco use and drug abuse. Please refrain from consuming alcohol at least 24 hours prior to your screening appointment.
Be sure to bring all of your medications with you to your screening appointment.
Please note, you need to 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.
You will be filling out paperwork for the study. Please arrive at least 30 minutes in advance of your screening appointment. If you are late for your appointment you may not be seen or may need to reschedule.