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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and tolerability of GT4P administered orally as a single dose, and twice daily for 7 consecutive days, to subjects with hepatic impairment with cirrhosis (Child-Pugh scores of A, B, or C) and to a gender matched and similar age control group with normal hepatic function.

Detailed description

Study acquired from Horizon in 2024.

Conditions

• Hepatic Encephalopathy
• Urea Cycle Disorders

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2006-09-01
• Completion: 2007-06-01
• First posted: 2009-09-30
• Last updated: 2024-06-20

Locations

2 sites across 1 country: Ukraine