ICON Early Phase Services is conducting a research study for healthy non-smoking Adults ages 18-55. The purpose of this study is to evaluate the safety and tolerability of an investigational drug nonalcoholic fatty liver disease (NAFLD). Another purpose of this study is to look into the interaction between either itraconazole (antifungal medication) or phenytoin (a medication used to help control seizures) when they are taken with the investigational drug. The study drug, itraconazole and phenytoin will be given as tablets or capsules orally. If you participate in Cohort 2, you will receive the study drug and phenytoin.
Or call 210-225-5437 for more information
Vital signs, ECGs, physical examinations, drug, tobacco and alcohol testing will be performed as part of the study. Blood and urine samples will also be obtained during this study.
Participants will complete:
- screening visit
- 24 consecutive overnights (admit day -1 and discharge Day 24)
- 1 Outpatient visits (Day 31)
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. For more information, see below.
Qualified participants may be compensated up to $9,000 for time and travel.
|Admit||May 03, 2021 Mon|
|Discharge||May 27 Thurs|
|Outpatient Visit||May 29 Sat|
If you are able to answer “YES” to the following statements, you may qualify for this study.
- I am a healthy non-smoking male or female meaning no significant medical conditions
- I am between 18 and 55 years old
- My BMI is between 19.0 and 32.0 kg/m2 and my weight is at least 110 pounds
- I have not participated in a clinical study of a drug or device within 30 days, or a study involving a biologic within 3 months prior to dosing
- If Female, I meet one of the following:
- Postmenopausal (no menses for 12 months)
- Surgically sterile
- Bilateral oophorectomy (removal of both ovaries), with or without hysterectomy, at least 6 weeks before study treatment.
- Bilateral tubal ligation (tying the tubes), at least 6 weeks before study treatment,
- Hysterectomy (removal of uterus)
- Child bearing and currently use one of the following and agree to not donate ova and agree to continue use from screening until for 30 days after the last visit – hormonal contraceptives (e.g. birth control pills) are not allowed because of safety concerns.
- Acceptable methods of non-hormonal contraception are:
- Intrauterine device (IUD).
- Bilateral tubal occlusion.
- Vasectomized partner (provided that your partner is the sole sexual partner and that the absence of sperm in the ejaculate has been confirmed).
- Sexual abstinence if it is the preferred and usual lifestyle. If you decide to choose abstinence as a method of contraception, you must refrain from heterosexual intercourse throughout the duration of the study and for 30 days after your last follow-up visit.
- If Male, and choose to have sex with women while in this study, you must use highly effective birth control such as a condom with spermicide and continue to use for 30 days after your last follow-up visit. If you have had a vasectomy you must still wear a condom during sex for the duration of the study and for 30 days after your last follow-up visit. You must also not donate sperm during the study and for 30 days after your last follow-up visit.
- I have suitable veins for multiple blood samples
- I am able to communicate effectively in English with the study personnel
Screening Reminders -
- 8 hours fasting is required for lab work (only water is allowed)
- If taking medications, bring them to your screening appointment.
- 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.
- Arrive 30 minutes before your appointment to complete paper work.
- GA 3705-0005 Cohort 2
- Healthy Adults - Not Currently Screening
- Male or Female
- Payment amount
- up to $9,000
- 18 - 55