Purpose:
• To determine how the investigational drug is broken down and removed from the body in volunteers with severe 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 study medication
Investigator: Thomas Marbury, MD
To qualify:
• 18 to 80 years old
• Must have a severe degree of liver impairment resulting from fatty liver disease, chronic Hepatitis C, or past history of alcohol related liver disease
• Volunteers may be taking medicines such as spironolactone, Lasix®, lactulose, Aldactone®, or rifaximin
• May also have fluid in your abdomen, cirrhosis, or encephalopathy (brain condition that causes irritability and/or trouble sleeping)
Length/Duration:
• Up to 8 days and 7 nights in our research facility
• Up to 6 follow-up visits
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 $6,150 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