Non-Alcoholic Fatty Liver Disease (NAFLD)
Non-Alcoholic Fatty Liver Disease (NAFLD).
An Adaptive Design Study for the Assessment of the Safety, Tolerability, and Pharmacokinetics of RYI-018 after Single Dosing in Subjects with Non-Alcoholic Fatty Liver Disease (NAFLD)
The sponsor is developing the product RYI-018 as a potential treatment for non-alcoholic fatty liver disease (NAFLD), which is a very common disorder and refers to a group of conditions where there is accumulation of excess fat in the liver of people who drink little or no alcohol. One form of NAFLD is non-alcoholic steatohepatitis (NASH) which is associated with an increased risk of liver cancer and heart disease. At present there are no approved treatments for NASH.
Eligible participants will be required to stay in the clinical unit two days prior to dosing (Day -2) until Day 2 of the study. If you are deemed eligible, you will check in to the clinical trial unit on the morning of Day -2 and if you remain eligible and are administered the study drug, then you will stay within the unit for safety monitoring until the last procedure has been completed on Day 2. This first visit is a total of 3½ days and 3 nights stay.
For the remaining dosing visits, you will also be asked to stay overnight within the unit for safety monitoring, for at least 24 hours after each dosing day occurs and until the last procedure has been completed for that visit. These dosing days will be on Day 8 (discharge on Day 9), Day 15 (discharge on Day 16), and Day 22 (discharge on Day 23). You will also be asked to stay overnight on Day 28 (discharge on Day 29), however there will be no dosing during this visit. These overnight visits will total 1½ days and 1 night stay each.
You will also need to return for follow-up visits (out-patient visits with no overnight stay) on Days 3, 5, 24, 26, 36, and 67.
The payment to participants who participate in and complete this study will be $5,430.70. This will be paid as instalments throughout the study on completion of certain milestones.
Participant payment is for your time, inconvenience and any minor discomfort you may have. Additional reimbursement for costs incurred due to extended travel, accommodation etc. will be reviewed on a case by case basis and may be paid to you on condition that evidence of the costs are provided e.g. receipts, travel log etc.
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