PURPOSE:
• To determine how a single oral dose of an investigational medication is broken down and removed from the body in volunteers with various degrees of 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 drug
TO QUALIFY:
• 18 to 75 years old
• Diagnosed with cirrhosis due to fatty liver disease, including NASH, or history of alcohol-related liver disease
• May be taking medicines such as spironolactone, furosemide, lactulose, or Xifaxan®
• May have fluid in your abdomen or previous encephalopathy (brain condition that causes irritability, sleepiness, or trouble sleeping)
LENGTH/DURATION:
• 1 eligibility screening visit
• 7 days and 6 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 $2,500 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