Summary:
ICON Early Phase Services is conducting a research study for healthy adults ages 18 to 60. The study drugs will be administered orally.
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
- 16 consecutive overnights
- 2 outpatient visits
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 may need to provide medical records at screening. For more information, see below.
- 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 ≥ 18 and ≤ 60 years old at screening
- My BMI is ≥ 18.0 and ≤ 30.0 kg/m2 at screening and I weigh at least 110 lbs
- I am a non-smoker and I have abstained from tobacco or nicotine-containing products (e.g., cigarettes, cigars, chewing tobacco, snuff, nicotine patches, electronic cigarettes) for 6 months prior to screening. I agree not to smoke 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 another trial of an investigational drug (or medical device)
- If Female, I am not pregnant or breastfeeding
- If Female and not capable of becoming pregnant, I have been postmenopausal for at least 2 years or I am surgically sterile (ovaries removed, tubes tied, uterus removed)
- If Male and I have a partner capable of becoming pregnant, I agree to a highly effective method of birth control during the study and for 3 months following last drug dose. Methods of birth control for you and your partner will be discussed at screening.
- If Male, I agree not to donate sperm during the study and for 3 months following last drug dose
- I am able to communicate effectively in English with the study personnel
- I do not have a history or presence of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at dosing), hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, renal, hepatic, psychiatric, or neurological disease
- I have not had previous gastrointestinal surgery such as the removal of parts of the stomach, bowel, liver, or pancreas
- I do not have a history of surgery or major trauma within 12 weeks of screening and I do not have surgery planned during the study
- I do not have evidence of atrial fibrillation, atrial flutter, complete bundle branch block, Wolf‑Parkinson‑White Syndrome, or a cardiac pacemaker
- I do not have known personal or family history of a congenital long QT syndrome (LQTS) heart condition or known family history of 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 taken any prescription medications or over-the-counter (OTC) drugs including herbal preparations or dietary supplements, or any drugs that induce or inhibit the study drug within 14 days of check-in, or requires continuing use during study participation
- I do not use or have used any medication within 1 month of dosing that prolongs the heart’s QT/QTc interval
I do not consume more than 4 cups of coffee daily and I am willing to abstain from consuming caffeine or xanthine-containing products (e.g., tea, coffee, chocolate, cola, etc.) from 48 hours prior to first dose until the end of the study
Qualified Participants May Receive:
Qualified participants may be compensated up to $4,500 for time and travel