Adults with non-alcoholic fatty liver disease (NAFLD)
ICON Early Phase Services is conducting a research study for non-smoking Adults ages 18-65 with NAFLD. The purpose of this study is to evaluate the safety and tolerability of an investigational drug for nonalcoholic fatty liver disease (NAFLD). The study drug will be given as a tablet orally once.
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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
- 5 consecutive overnights (admit day -1 and discharge Day 5)
- 1 Outpatient visits (Day 8)
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 $2,100 for time and travel.
|Part 2 - Cohort 3A||Part 2 - Cohort 3B|
|Admit||Apr 27, 2021 Tue||May 24, 2021 Mon|
|Discharge||May 02 Sun||May 29 Sat|
|End of Study Visit||May 05 Wed||Jun 01 Tue|
If you are able to answer “YES” to the following statements, you may qualify for this study.
- I am a non-smoking male or female with nonalcoholic fatty liver disease (NAFLD)
- I am between 18 and 65 years old
- I have not participated in a clinical study of a drug or device within 30 days of dosing, or a clinical 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 not donate ova and agree to continue use from screening until for 30 days after the last visit.
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.
- Hormonal contraceptives with a failure rate of <1%
- 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 Part 2
- Adults with Non-alcoholic fatty liver disease
- Male or Female
- Payment amount
- up to $2,100
- 18 - 65