A study of glyceryl tri-(4-phenylbutyrate) (GT4P)

Subjects were required to fulfill the following criteria in order to participate in the study: - Males aged 18 to 45 years of age - Ability 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 - Subjects who were in good health as determined by a medical history, physical examination, serum chemistry, hematology, urinalysis, 12 lead ECG, and vital signs - Weight within the range of 60–120 kg

Subjects who fulfilled any of the following criteria were excluded from the study: - Clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurologic, immunologic, or psychiatric disorder(s), as determined by the investigator - Clinically significant abnormal laboratory values (as determined by the investigator) - Significant illness within 14 days prior to screening - Any disorder that might significantly interfere with the absorption, distribution, metabolism, or excretion of any drug - Use of any prescription medication within 14 days prior to screening - Use of dietary supplements, herbal medicines, vitamins, or over-the-counter medication(s) (with the exception of acetaminophen ≤ 500 mg/day) within 10 days prior to first dosing - Positive drugs of abuse urine test at screening or pre-dose day (cocaine, amphetamines, barbiturates, opiates, benzodiazepines, cannabinoids, methadone) - Positive alcohol breath test at screening or pre-dose day - Donation or loss of blood (500 ml or more) within 30 days prior to first dosing, or during the study - Donation or loss of plasma within 7 days prior to first dosing, or during the study - History of or current hepatitis or carriers of hepatitis B surface antigen (HBsAg) and/or hepatitis C antibodies (anti-HC) - History of acquired immunodeficiency syndrome (AIDS) or determined HIV positive at screening - Use of any investigational drug within 12 weeks prior to first dosing - Known hypersensitivity to sodium phenylbutyrate or similar drugs - Previous exposure to sodium phenylbutyrate