Purpose:
• The overall purpose of this study is to find out if the study drug is absorbed or eliminated from the body differently in individuals with normal liver function compared to individuals 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 of study drug
Investigator: Thomas Marbury, MD
To qualify:
• 18 to 75 years old
• Must have decreased liver function or disease such as fatty liver disease (NASH), history of 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)
• Non-nicotine users
Length/Duration:
• 14 consecutive days and 13 nights in our research facility
• 1 follow-up phone call
Location: 5055 South Orange Avenue, Orlando, FL 32809
Compensation:
Qualified participants will receive study medication, study related physical exams and laboratory tests
Qualified study participants will be compensated up to $6,450 for time and travel
Whom to Contact: Recruitment Department at 407-240-7876
Orlando Clinical Research Center
5055 South Orange Avenue
Orlando, FL 32809
Recruiting Number: 407.240.7878