CLINICAL TRIALS PROFILE FOR SODIUM BENZOATE; SODIUM PHENYLACETATE

All Clinical Trials for SODIUM BENZOATE; SODIUM PHENYLACETATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00004767 ↗	Phase II Study of Sodium Phenylbutyrate, Sodium Benzoate, Sodium Phenylacetate, and Dietary Intervention for Urea Cycle Disorders	Completed	Johns Hopkins University	Phase 2	1985-01-01	OBJECTIVES: I. Assess the safety and efficacy of sodium phenylbutyrate, sodium benzoate, sodium phenylacetate, and dietary intervention in patients with urea cycle disorders.
NCT00004767 ↗	Phase II Study of Sodium Phenylbutyrate, Sodium Benzoate, Sodium Phenylacetate, and Dietary Intervention for Urea Cycle Disorders	Completed	National Center for Research Resources (NCRR)	Phase 2	1985-01-01	OBJECTIVES: I. Assess the safety and efficacy of sodium phenylbutyrate, sodium benzoate, sodium phenylacetate, and dietary intervention in patients with urea cycle disorders.
NCT00597909 ↗	Efficacy and Safety Study of Ammonul® in Patients With Grade 3 or 4 Hepatic Encephalopathy	Terminated	Horizon Pharma Ireland, Ltd., Dublin Ireland	Phase 2	2007-12-01	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).
NCT00977600 ↗	A Study of Glyceryl Tri-(4-phenylbutyrate) (GT4P)	Completed	Ucyclyd Pharma, Inc.	Phase 1	2005-03-01	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.
NCT00977600 ↗	A Study of Glyceryl Tri-(4-phenylbutyrate) (GT4P)	Completed	Horizon Pharma Ireland, Ltd., Dublin Ireland	Phase 1	2005-03-01	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.
NCT04155567 ↗	A Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability of TAK-123 After Intravenous Infusion in Japanese Healthy Adult Male Participants	Completed	Takeda	Phase 1	2019-11-13	The purpose of this study is to evaluate the PK, safety and tolerability of phenylacetate and benzoate after intravenous administration of TAK-123 in Japanese healthy adult male participants.

Clinical Trial Conditions for SODIUM BENZOATE; SODIUM PHENYLACETATE

Condition Name

Condition Name for SODIUM BENZOATE; SODIUM PHENYLACETATE
Intervention	Trials
Amino Acid Metabolism, Inborn Errors	1
Healthy	1
Healthy Volunteers	1
Hepatic Encephalopathy	1

Condition MeSH

Condition MeSH for SODIUM BENZOATE; SODIUM PHENYLACETATE
Intervention	Trials
Hepatic Encephalopathy	1
Brain Diseases	1
Urea Cycle Disorders, Inborn	1
Metabolism, Inborn Errors	1

Clinical Trial Locations for SODIUM BENZOATE; SODIUM PHENYLACETATE

Trials by Country

Trials by Country for SODIUM BENZOATE; SODIUM PHENYLACETATE
Location	Trials
United States	2
Japan	1
Ukraine	1

Trials by US State

Trials by US State for SODIUM BENZOATE; SODIUM PHENYLACETATE
Location	Trials
Texas	1
California	1

Clinical Trial Progress for SODIUM BENZOATE; SODIUM PHENYLACETATE

Clinical Trial Phase

Clinical Trial Phase for SODIUM BENZOATE; SODIUM PHENYLACETATE
Clinical Trial Phase	Trials
Phase 2	2
Phase 1	2

Clinical Trial Status

Clinical Trial Status for SODIUM BENZOATE; SODIUM PHENYLACETATE
Clinical Trial Phase	Trials
Completed	3
Terminated	1

Clinical Trial Sponsors for SODIUM BENZOATE; SODIUM PHENYLACETATE

Sponsor Name

Sponsor Name for SODIUM BENZOATE; SODIUM PHENYLACETATE
Sponsor	Trials
Horizon Pharma Ireland, Ltd., Dublin Ireland	2
National Center for Research Resources (NCRR)	1
Ucyclyd Pharma, Inc.	1

Sponsor Type

Sponsor Type for SODIUM BENZOATE; SODIUM PHENYLACETATE
Sponsor	Trials
Industry	3
Other	2
NIH	1