Summary:
ICON Early Phase Services is conducting a research study for healthy adults ages 18-55. This study is being done to test the study drug’s effect on the heart rate.
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
- 8 overnights (over 4 periods)
- 4 partial days
- 1 outpatient visits
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 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 and I weigh at least 110 lbs.
- I do not use tobacco or nicotine-containing products (e.g., cigarettes, cigars, chewing tobacco, snuff, vape) and I have not used any of these products within 3 months of dosing. I agree to abide by the rules of the clinic, which is a non-smoking facility.
- I have not taken any other investigational drugs or participated in a clinical study within 30 days or 5 half-lives (whichever is longer) of the investigational drug(s) used in the previous study, and prior to first dose in this study. I am not currently participating in another clinical study.
- I have not previously received palovarotene
- If Female, I am not pregnant or breastfeeding. I do not plan to become pregnant or donate eggs during the study and for 30 days after the last visit.
- If Female and sexually active and capable of becoming pregnant, I agree to use two effective methods of birth control (in use for 30 days prior to dosing) during dosing and for one month after dosing (NOTE: At least one form of birth control must be highly effective.) * see below for methods
- If Female and sexually active and capable of becoming pregnant, I agree to remain abstinent during dosing and for 1 month after dosing, or, use two effective methods of birth control. (NOTE: At least one form of birth control must be highly effective.)
- If Female and taking oral contraceptives, I have been on a stable dose for 3 months before dosing and I will remain on the same dose throughout the study
- Highly Effective Methods of birth control include: *Must be using 1 of these.
- Combined (estrogen- and progesterone-containing) hormonal contraception (oral, implant, injectable) for at least 30 days
- Progesterone-only hormonal contraceptives (oral, implant, injectable)
- Placement of an intrauterine device (IUD) or intrauterine system (IUS)
- Vasectomized partner
- Heterosexual abstinence if this is the preferred and usual lifestyle
- Bilateral tubal occlusion or bilateral tubal ligation (must bring documentation)
Plus using another effective method of birth control:
- Barrier forms (always ued with spermicide) - diaphragm, cervical cap
- Barrier forms (used with or without spermicide) - male latex condom
- Others - vaginal sponge (contains spermicide)
- If Male and I have a partner capable of becoming pregnant, I agree to remain abstinent during dosing and for 1 month after dosing, or, use effective methods of birth control (one form must be highly effective)
- If Male and I am sexually active, I agree to use one effective method of birth control during dosing and for 1 month after dosing
- If Male, I agree not to donate sperm from screening through 30 days after last dose
- I am able to communicate effectively in English with the study personnel
- I do not have a history or current evidence of a clinically significant or uncontrolled disease
- I do not have a medical condition that could potentially be aggravated by a systemic retinoid
- I have not been exposed to synthetic oral retinoids, or creams containing retinoids, within 30 days prior to informed consent
- I do not have a history or surgery or major trauma within 12 weeks of screening and I do not plan to have surgery during the study
- I do not have a recent history of alcohol abuse, illicit drug use, physical dependence to any opioid, or any history of drug abuse or addiction
- I have not consumed more than 28 units of alcohol per week at any time in the 6 months before dosing
- I have not recently taken any drug, including prescription and nonprescription medications, herbal remedies, or vitamin supplements. (NOTE: Thyroid hormone replacement medication may be permitted depending upon dosing. Hormone replacement therapy and hormonal contraceptives are allowed.)
- I have not recently used any over-the-counter (OTC) medication, vitamin or supplement (including omega-3 fish oils)
- I have not received a vaccination with 14 days prior to first dose
- I do not have a history of allergy or hypersensitivity to retinoids, gelatin, or lactose, or a known hypersensitivity to other drugs including moxifloxacin, ciprofloxacin, and levofloxacin
- I have not recently donated blood and I do not plan to donate blood
- I have not recently donated plasma
- I do not plan to donate plasma or blood for the 3 months following study completion
- I do not have any heart disease
- I am able to abstain from consuming Seville oranges, grapefruit (fruit and juice), starfruit, alcohol products, all products containing xanthines or caffeine (e.g., coffee, tea, chocolate, cola beverages, energy drinks), poppy seeds, any tobacco or nicotine-containing products as required while on study
- I am able to refrain from strenuous activity (e.g., sports) for 4 days prior to check-n and through the follow-up visit
- I am able to consume a high-fat, high-calorie breakfast
- I am able to swallow an oral dosage form of medication
- Clearance for the drug(s) used in the study is 5 half lives or 30-days.
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 an 8-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 8 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.
Qualified Participants May Receive:
Qualified participants may be compensated up to $5,300 for time and travel.