A study of glyceryl tri-(4-phenylbutyrate) administered orally as a single dose, and twice daily for seven consecutive days to subjects with hepatic impairment with cirrhosis and to a control group

Subjects were required to fulfill the following criteria in order to participate in the study: Screening: - Males or females aged ≥ 18 years of age - Able to provide written informed consent before any study-related procedures, and ability, in the opinion of the Investigator, to comply with all the requirements of the study - Classification to one of the following: ~current diagnosis of hepatic impairment with cirrhosis ~healthy subject - Subjects with hepatic impairment with cirrhosis were classifiable to one of the following groups: ~Child-Pugh score A ~Child-Pugh score B ~Child-Pugh score C - Subjects with hepatic impairment with cirrhosis who were on a therapeutic regimen of lactulose must have been on a stable dose for ≥ 30 days prior to screening - If female, a negative pregnancy test at screening and pre-dose on day 0, or a documented sterilization procedure; a female of child-bearing potential must have been using a medically approved birth control method and must have agreed to use the same method of contraception during the full course of the study (on pre-dose day 0 as well as at screening) - Weight within the range of 60-100 kg (at screening and pre-dose on day 0) - Willing to stop taking any medication that the Sponsor and the Investigator felt was not appropriate for use during the study, beginning 2 days before dosing and throughout the study

Subjects who fulfilled any of the following criteria were excluded from the study: Screening: - Clinically significant history or evidence of cardiovascular, respiratory, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s), as determined by the Investigator - Serum sodium < 120 mEq/L - Serum creatinine ≥ 1.5 upper limit of normal - Potassium ≤ 3.5 mEq/L - Other laboratory values outside the normal range which were determined to be clinically significant by the Investigator - Significant illness within the last 14 days - Oral temperature > 38.5°C or < 36°C and/or a suspected site of active infection - Inflammatory bowel disease or malabsorption defined with steatorrhea - Active gastrointestinal bleeding, defined as melena, hematochezia, or hematemesis requiring hospitalization within the last 30 days - Use of probenecid, valproate, or corticosteroids within the last 24 hours - Use of any medication, other than those approved by the Sponsor and Investigator, in the last 48 hours - History of seizures within the last 72 hours - Positive drugs of abuse urine test - Positive alcohol breath test - Donation or loss of blood (500 mL or more) within the last 30 days - Donation or loss of plasma within the last 7 days - History of acquired immunodeficiency syndrome (AIDS) or determined human immunodeficiency virus (HIV) positive - Hepatitis B or C (HBV; HCV) positive (healthy volunteers only) - Use of any investigational drug within the last 30 days - Known hypersensitivity to sodium phenylbutyrate or similar drugs - Emergency hospitalization within the last 90 days - Intake of alcohol in the last 7 days Pre-dose (days 0 and 7): - Significant illness or emergency hospitalization since the last study visit - Oral temperature > 38.5°C or < 36°C and/or a suspected site of active infection - Use of probenecid, valproate, or corticosteroids within the last 24 hours - Use of any non-approved medication (by the Sponsor/Investigator) within the 48 hours before dosing - History of seizures within the last 72 hours - Positive drugs of abuse urine test - Positive alcohol breath test - Donation or loss of blood (500 mL or more) or plasma since the last study visit - Use of any investigational drug since the last study visit - Intake of alcohol in the last 7 days