Purpose :
• To determine how the investigational drug is broken down and removed from the body in volunteers with liver impairment when compared to volunteers with normal liver function
• Information regarding safety and side effects that may occur will also be collected
• This study is for research purposes only and is not intended to treat your liver disease
Method of Administration: Single oral dose of the investigational drug
Investigator: Thomas Marbury, MD
To qualify:
• 18 to 80 years old
• Must have decreased liver function or disease such as fatty liver disease (NASH), hepatitis C (if successfully treated), past history of alcohol related liver disease or cirrhosis
• Volunteers may be taking medicines such as spironolactone, Lasix®, lactulose, Aldactone®, or rifaximin (Xifaxan®)
• May also have fluid in your abdomen, cirrhosis, or encephalopathy (brain condition that causes irritability and/or trouble sleeping)
Length/Duration:
• 9 consecutive days and 8 nights in our research facility
• 1 follow-up visit
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 $4,150 for time and travel
Whom to Contact: Recruitment Department: 407-240-7876
Orlando Clinical Research Center
5055 South Orange Avenue
Orlando, FL 32809
Recruiting Number: 407.240.7878