Current Study: G 8

Purpose:

• The overall purpose for this study is to find out if the study drug is absorbed or eliminated differently in women with normal liver function compared to women with severe impaired liver function. Another purpose is to assess the safety and tolerability of the drug in women 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 of study drug

Investigator: Thomas Marbury, MD

To qualify:

• Women that are postmenopausal or have had a hysterectomy
• 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
• 12 days and 11 nights in our research facility
• 1 follow-up phone call

Location: 5055 South Orange Avenue, Orlando, FL 32809

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

Compensation: Qualified female participants will be compensated up to $4,525 for time and travel

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