NCT00986895View on ClinicalTrials.gov

A Study of Glyceryl Tri-(4-phenylbutyrate) Administered Orally as a Single Dose, and Twice Daily for Seven Consecutive Days to Subjects With Hepatic Impairment With Cirrhosis and to a Control Group

PHASE1CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

September 30, 2006

Study Completion Date

June 30, 2007

Conditions
Hepatic EncephalopathyUrea Cycle Disorders
Interventions
DRUG

HPN-100

HPN-100 is a triglyceride that has a similar mechanism of action as NaPBA. It is a liquid with minimal taste and odor. HPN-100 is broken down to phenylbuteric acid (PBA). PBA is converted to phenylacetic acid (PAA) that is the active metabolite. Three teaspoons of HPN-100 (\~17.4mL) delivers an equivalent amount of PBA to40 tablets of NaPBA.

Trial Locations (2)

61057

National University of Pharmacy, Kharkiv

61128

Department of General Surgery #2; Kharkiv State Medical University, Kharkiv

Sponsors

Lead Sponsor

Amgen
All Listed Sponsors
collaborator

Ucyclyd Pharma, Inc.

OTHER

lead

Amgen

INDUSTRY

NCT00986895 - A Study of Glyceryl Tri-(4-phenylbutyrate) Administered Orally as a Single Dose, and Twice Daily for Seven Consecutive Days to Subjects With Hepatic Impairment With Cirrhosis and to a Control Group | Biotech Hunter | Biotech Hunter