Status:
COMPLETED
A Study of Glyceryl Tri-(4-phenylbutyrate) (GT4P)
Lead Sponsor:
Amgen
Collaborating Sponsors:
Ucyclyd Pharma, Inc.
Conditions:
Healthy
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief 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.
Detailed Description
A randomized, open-label, four-treatment, four-period crossover study in which healthy male subjects received a single dose of each of the following four treatments on four separate dosing days, 7 day...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2005
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00977600
Start Date
March 1 2005
End Date
July 1 2005
Last Update
June 20 2024
Active Locations (1)
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1
Medical Sanitary Division #2
Kharkiv, Ukraine, 61011