A Study of Glyceryl Tri-(4-phenylbutyrate) (GT4P)

• Status: Completed
• Trial end date: 2005-07-01
• Target enrollment: 0
• Participant gender: Male

Summary

To determine the safety and tolerability of single oral doses of HPN-100 as a formulation (GT4P-F) and GT4P as the active pharmaceutical ingredient (GT4P-API) administered to healthy male subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Horizon Pharma Ireland, Ltd., Dublin Ireland
• Collaborator: Ucyclyd Pharma, Inc.
• Treatments: 4-phenylbutyric acid; Phenylacetic acid; Sodium Benzoate

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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