ICON Early Phase Services is conducting a research study for healthy adult male age 18-55. This study is being done to test a potential treatment for diseases that generate excessive bone formation and bone tumors. This study will assess the amount of study drug present in semen samples.
Vital signs, ECGs, physical examinations and drug and alcohol screens will be performed. Blood, urine and semen samples will also be obtained during this study.
Participants will complete:
- 1 screening visit
- 8 consecutive overnights
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 male, meaning no significant medical conditions (no reproductive or urological disorders and MUST NOT have been vasectomized)
- 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 do not use tobacco or nicotine-containing products of any type (e.g., cigarettes, cigars, chewing tobacco, snuff). I agree not to use these products while on study and to abide by the rules of the clinic, which is a non-smoking facility.
- I have not taken an investigational drug, or participated in any interventional clinical study, within 30 days or 5 half-lives (if known) prior to first dose of study drug. I am not currently participating in another clinical study.
- I have not had a vasectomy
- If I have a partner capable of becoming pregnant, I agree to use condoms from screening and until 30 days after last dose
If I have a partner capable of becoming pregnant, my partner must be willing to use two methods of contraception, one of which must be highly effective (intrauterine system or hormonal contraception) from screening through 30 days after last dose
My partner must not be pregnant, breast feeding, plan to become pregnant, or donate ova for in vitro fertilization during the study period or for 30 days following my last study visit
I agree not to donate sperm from screening through 30 days after last dose other than for study purposes (cannot masturbate and ejaculate while in the clinic except to provide semen samples)
I am able to communicate effectively in English with the study personnel
I am able to swallow an oral solid-dosage form of medication
I am able to consume a standardized high fat high calorie meal
I do not have a history or current evidence of uncontrolled disease
I have not recently had surgery or major trauma
I have not recently been hospitalized for any significant medical disorder
I do not have a recent history of alcohol abuse, illicit drug use, physical dependence to any opioid, or any drug abuse or addiction
I have not recently consumed more than 4 alcoholic beverages/day
I have not recently been exposed to synthetic oral retinoids, or creams containing retinoids, and I do not have any condition that may potentially be aggravated by a systemic retinoid
I do not have a history, allergy or hypersensitivity to retinoids, gelatin or lactose
I have not recently taken any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements
I have not recently donated blood or blood products.I agree not to donate blood or blood products for 3 months following study completion.
I am able to comply with restrictions on juices and foods, alcohol products, xanthine or caffeine products, consumption of poppy seeds and tobacco or nicotine-containing products as required by the study
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.
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.