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

2014-08-27 03:19:19 | BioPortfolio


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.


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 days apart:

- Oral sodium phenylbutyrate (Buphenyl®) equivalent to 3 g/m2 of 4-phenylbutyric acid (PBA) per dose

- Oral GT4P-F mole equivalents to 3 g/m2 of PBA per dose

- Oral GT4P-API mole equivalents to 3 g/m2 of PBA per dose

- Intravenous 10% sodium phenylacetate plus 10% sodium benzoate (Ammonul®) 2.75 g/m2

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment




HPN-100, Ammonul, Buphenyl


Medical Sanitary Division #2




Hyperion Therapeutics, Inc.

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:19:19-0400

Clinical Trials [7 Associated Clinical Trials listed on BioPortfolio]

Arginine and Buphenyl in Patients With Argininosuccinic Aciduria (ASA), a Urea Cycle Disorder

Urea cycle disorders are inherited illnesses in which the body does not produce enough of the chemicals that remove ammonia, a byproduct of protein metabolism, from the blood stream. Eleva...

Mechanism of Fatty Acid-induced Impairment of Glucose-simulated Insulin Secretion - Effect of Buphenyl

An increase of plasma free fatty acids impairs insulin secretion and insulin sensitivity, thereby playing an important role in causing type 2 diabetes. Lipotoxicity plays an important ro...

Efficacy and Safety Study of Ammonul® in Patients With Grade 3 or 4 Hepatic Encephalopathy

The primary purpose of this study is to evaluate the safety and effectiveness of Ammonul® in subjects who become hospitalized with Grade 3 or 4 hepatic encephalopathy (HE).

Study of the Efficacy and Safety of HPN-100, Glyceryl Tri-(4-phenylbutyrate), for the Treatment of Adults With Urea Cycle Disorders (Help UCD)

This is a randomized, active-controlled, double-blind, cross-over study designed to enroll subjects with UCDs who are being treated with NaPBA. Subjects will be randomly assigned to receiv...

Study Evaluating MOA-728 Administered in Healthy Men

Absorption, distribution, metabolism, and excretion (ADME) study with 14C in healthy young men.

PubMed Articles [4379 Associated PubMed Articles listed on BioPortfolio]

Defining and Estimating Healthy Aging in Spain: A Cross-sectional Study.

Using an operational continuum of healthy aging developed by U.S. researchers, we sought to estimate the prevalence of healthy aging among older Spaniards, inform the development of a definition of he...

Clinical Relevance and Cost-Savings of Levocarnitine Versus Ammonul in the Management Of Hyperammonemia in a Cancer Patient: The Impact of a Clinical Pharmacist.

Hyperammonemia, a relatively uncommon condition characterized by elevated ammonia levels in the blood, presents with varied physiological etiologies that may send patients to the intensive care unit (...

Effects of a healthy-eater self-schema and nutrition literacy on healthy-eating behaviors among Taiwanese college students.

Unhealthy eating behaviors contribute to obesity and chronic illness. This study examined the relative contributions of a healthy-eater self-schema (a self-conception as a healthy eater) and nutrition...

Healthy China 2030, a breakthrough for improving health.

China has the largest population in the world, and its health levels have greatly affected the healthy development of the population of the world. Healthy China 2030 is a breakthrough for ensuring tha...

Healthy People for the 21st Century: Understanding Use of Healthy People 2020 as a Web-Based Initiative.

This study assesses how the nation's preeminent health promotion and disease prevention initiative, Healthy People, is utilized by key stakeholders.

Medical and Biotech [MESH] Definitions

Healthy People Programs are a set of health objectives to be used by governments, communities, professional organizations, and others to help develop programs to improve health. It builds on initiatives pursued over the past two decades beginning with the 1979 Surgeon General's Report, Healthy People, Healthy People 2000: National Health Promotion and Disease Prevention Objectives, and Healthy People 2010. These established national health objectives and served as the basis for the development of state and community plans. These are administered by the Office of Disease Prevention and Health Promotion (ODPHP). Similar programs are conducted by other national governments.

Governmental guidelines and objectives pertaining to public food supply and nutrition including recommendations for healthy diet and changes in food habits to ensure healthy diet.

Surgical reinnervation of a denervated peripheral target using a healthy donor nerve and/or its proximal stump. The direct connection is usually made to a healthy postlesional distal portion of a non-functioning nerve or implanted directly into denervated muscle or insensitive skin. Nerve sprouts will grow from the transferred nerve into the denervated elements and establish contact between them and the neurons that formerly controlled another area.

Process of evaluating the health of a patient and determining if they are healthy enough for surgery.

Dietary patterns which have been found to be important in reducing disease risk.

More From BioPortfolio on "A Study of Glyceryl Tri-(4-phenylbutyrate) (GT4P)"

Quick Search


Relevant Topic

Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...

Searches Linking to this Trial