Current Study: R8

Purpose:

• The overall purpose for this study is to find out if the study drug is absorbed or eliminated differently in people with normal liver function compared to people with impaired liver function. Another purpose is to assess the safety and tolerability of the drug in people with healthy to impaired liver function.
• This study is for research purposes only and is not intended to treat your liver disease

Method of Administration:
Single oral dose

Investigator: Thomas Marbury, MD

To qualify:

• 18 to 65 years old
• Must have decreased liver function or disease such as fatty liver disease (NASH), Hepatitis C, past history of alcohol related liver disease or cirrhosis
• Volunteers may be taking medicines such as spironolactone (Aldactone®), furosemide (Lasix®), lactulose, or rifaximin (Xifaxan®)
• May also have ascites (fluid in your abdomen) or encephalopathy (brain condition that causes irritability or trouble sleeping)
• Not currently taking any controlled substances, such as opiates or benzodiazepines

Length/Duration:
• 1 eligibility screen visit
• 9 days and 8 nights in our research facility

Location: 5055 South Orange Avenue, Orlando, FL 32809

Qualified participants will receive study medication, study related physical exams and laboratory tests

Compensation Qualified participants may be compensated up to $2,650 for time and travel

Whom to Contact Recruitment Department: 407-240-7876