Purpose:
• To determine how an investigational drug is broken down and removed from the body in volunteers with liver impairment relative to volunteers with normal liver function
• Information regarding 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 75 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®, neomycin, or rifaximin
• May also have fluid in your abdomen, cirrhosis, or encephalopathy (brain condition that causes irritability or trouble sleeping
Length/Duration:
• Up to 6 days and 7 nights in our research facility
• 1 follow-up phone call
Location: 5055 South Orange Avenue, Orlando, FL 32809
Compensation: Qualified participants will receive the investigational drug, study related physical exams and laboratory tests
Qualified study participants will be compensated up to $2,550 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