ICON Early Phase Services is conducting a research study for healthy adults ages 18-45. This study is being done to test the effects of the study drug on cardiac repolarization.
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
- 17 consecutive overnights
- 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 45 (inclusive) years old
- My BMI is between 18.0 and 30.0 kg/m2 (inclusive ) and I weigh between 88 and 264 lbs.
- I have not used nicotine-containing products within the past 45 days (including snuff, chewing tobacco, cigars, pipes or nicotine-replacement products such as nicotine chewing gum and electronic cigarettes). I agree not to use any of these products through the follow-up visit.
- I have not received any investigational drug, device or therapy within 35 days before screening
- If Female, I am not pregnant or breastfeeding
- If Female and capable of becoming pregnant, I agree to use a highly effective method of birth control. Methods of birth control include:
- established hormonal birth control plus a barrier method
- double barrier method: intrauterine device plus condom
- double barrier method: spermicidal gel plus condom
- If Female and not capable of becoming pregnant, I have been postmeno- pausal for at least 1 year, or I have been surgically sterile (uterus removed, tubes removed) for at least 6 months
- If Male and I have a partner capable of becoming pregnant, I agree to use birth control as described above from screening through the follow-up visit
- If Male, I am willing to abstain from sperm donation from the time of screening through the follow-up visit
- I am able to communicate effectively in English with the study personnel
- I do not have a current diagnosis of sleep apnea
- I do not have a clinically significant medical, surgical, postsurgical, psychiatric or substance abuse condition within 6 months of screening
- I do not have a current malignancy, current systemic chemotherapy, or cancer diagnosis within 5 years before screening (excluding squamous or basal cell carcinoma of the skin that has been fully removed)
- I do not have clinically significant allergic reactions to opioids, or any prior history of an adverse reactions
- I do not have a history of hypersensitivity or allergy to moxifloxacin (or any other study medication) or history of tendonitis or tendon rupture with moxifloxacin (or any other similar type drug)
- I do not have opioid tolerance or a physical dependence on opioids
- I am not currently taking moderate or strong CYP2D6 or CYP3A4 inhibitors
- I am willing to avoid consuming quinine-containing products (such as tonic water)
- I am willing to avoid consuming caffeine-containing products
- I am willing to avoid consuming poppy seed-containing products
- I have not recently used oral/inhaled/injected corticosteroids
- I have not recently used any prescription or over-the-counter drugs
- I have not recently consumed alcohol
- I do not have a history of alcohol abuse and I do not have current alcohol abuse
- I do not have a history of drug abuse and I do not have current drug abuse
- I do not have a history of heart problems and I do not have a current heart problem
- I have not donated blood or blood products within 30 days prior to first dose.
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.
Be advised that you may need to provide medical records as part of the screening process for this study. If possible, please bring your full medical records with you to your screening appointment. If you cannot bring your records with you, you must provide them before you can admit to the study. Note that full medical records include surgical reports.