ICON Early Phase Services is conducting a research study for healthy adults ages 18-65. This study is being done to test a potential treatment for classic galactosemia (CG).
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
- 3 consecutive overnights
- 1 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 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 65 (inclusive) years old
- My BMI is <35 kg/m2 and I weigh at least 110 lbs.
- I have not participated in another clinical trial of an investigational product (randomized subjects only) within 30 days prior to the 1st dose of study drug
- If Female, I am not pregnant or breastfeeding
- If Female, I am not capable of becoming pregnant (surgically sterile from bilateral tubal ligation, hysterectomy or bilateral oophorectomy at least 6 months prior to 1st dose, or, postmenopausal for at least 1 year), OR, I agree to use an acceptable form of birth control from screening until 30 days after study completion.
Acceptable methods of birth control include:
- Vasectomized partner (at least 6 months prior to dosing)
- Non-surgical permanent sterilization (e.g., Essure® procedure) at least 3 months prior to dosing
- Double barrier method (e.g., diaphragm plus condom)
- Intrauterine device (IUD)
- Abstinence (and I agree to use a double barrier method if I become sexually active during the study)
- Implanted or intrauterine hormonal contraceptives in use for ≥6 consecutive months prior to dosing
- Oral, patch, or injected contraceptives, or vaginal hormonal device (i.e., NuvaRing®) in use for ≥3 consecutive months prior to dosing
- If Female, I am not receiving regular medical treatment other than the birth control methods (as described above)
- If Male, I am surgically sterile from a vasectomy at least 6 months prior to screening, OR, I agree to use an acceptable form of birth control from screening until 30 days after the end of study visit with a sexual partner who could become pregnant
- I am not a smoker and I have not used tobacco or nicotine-containing products within 6 months prior to 1st dose. 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 am able to communicate effectively in English with the study personnel
- I do not have any prior history of substance abuse (including alcohol) and I have not received any treatment for substance abuse
- I do not have a history of significant drug allergy or drug hypersensitivity
- I have not had a significantly abnormal diet within 4 weeks of 1st dose
- I have not used any over-the-counter (OTC) medications recently (e.g., nutritional or dietary supplements, herbal preparations, or vitamins) recently and I agree not to use these products until the end of study visit
- I have not used any prescription medications recently and I agree not to use these products until the end of study visit. (NOTE: Females hormonal contraceptives and hormonal replacement therapy maintained for more than one month prior to screening and continued through the end of study visit are allowed.)
- I have not recently consumed beverages or foods that contain alcohol, high levels of sorbitol, grapefruit, poppy seeds, broccoli, Brussels sprouts, pomegranate, star fruit, char-grilled meat, or caffeine/xanthine products and I agree not to consume these products until the end of study visit
- I have not donated blood or plasma within 3 months prior to first dose
- I agree not to engage in strenuous exercise, as directed, prior to 1st dose and through the end of study visit.
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