Current Study: A9

Purpose:
• The overall purpose for this study is to find out if the investigational 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 study medication 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 subcutaneous injection

Investigator: Thomas Marbury, MD

To qualify:

• 18 years to 75 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)

Length/Duration:
• 1 eligibility screening visit
• 8 days and 7 nights in our research facility
• 4 follow-up visits

Location: 5055 South Orange Avenue, Orlando, FL 32809

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

Compensation: Qualified participants will be compensated up to $4,700 for study-related time and
procedures

Whom to Contact: Recruitment Department: 407-240-7876