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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

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ClinicalTrials.gov Identifier: NCT00986895
Recruitment Status : Completed
First Posted : September 30, 2009
Last Update Posted : January 16, 2017
Sponsor:
Collaborator:
Information provided by:

September 15, 2009
September 30, 2009
January 16, 2017
September 2006
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The rate of adverse event
Same as current
Complete list of historical versions of study NCT00986895 on ClinicalTrials.gov Archive Site
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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
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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.
Not Provided
Interventional
Phase 1
Masking: None (Open Label)
Primary Purpose: Treatment
  • Hepatic Encephalopathy
  • Urea Cycle Disorders
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.
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McGuire BM, Zupanets IA, Lowe ME, Xiao X, Syplyviy VA, Monteleone J, Gargosky S, Dickinson K, Martinez A, Mokhtarani M, Scharschmidt BF. Pharmacology and safety of glycerol phenylbutyrate in healthy adults and adults with cirrhosis. Hepatology. 2010 Jun;51(6):2077-85. doi: 10.1002/hep.23589.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
June 2007
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Inclusion Criteria:

Subjects were required to fulfill the following criteria in order to participate in the study:

Screening:

  • Males or females aged ≥ 18 years of age
  • Able 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
  • Classification to one of the following:

    • current diagnosis of hepatic impairment with cirrhosis
    • healthy subject
  • Subjects with hepatic impairment with cirrhosis were classifiable to one of the following groups:

    • Child-Pugh score A
    • Child-Pugh score B
    • Child-Pugh score C
  • Subjects with hepatic impairment with cirrhosis who were on a therapeutic regimen of lactulose must have been on a stable dose for ≥ 30 days prior to screening
  • If female, a negative pregnancy test at screening and pre-dose on day 0, or a documented sterilization procedure; a female of child-bearing potential must have been using a medically approved birth control method and must have agreed to use the same method of contraception during the full course of the study (on pre-dose day 0 as well as at screening)
  • Weight within the range of 60-100 kg (at screening and pre-dose on day 0)
  • Willing to stop taking any medication that the Sponsor and the Investigator felt was not appropriate for use during the study, beginning 2 days before dosing and throughout the study

Exclusion Criteria:

Subjects who fulfilled any of the following criteria were excluded from the study:

Screening:

  • Clinically significant history or evidence of cardiovascular, respiratory, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s), as determined by the Investigator
  • Serum sodium < 120 mEq/L
  • Serum creatinine ≥ 1.5 upper limit of normal
  • Potassium ≤ 3.5 mEq/L
  • Other laboratory values outside the normal range which were determined to be clinically significant by the Investigator
  • Significant illness within the last 14 days
  • Oral temperature > 38.5°C or < 36°C and/or a suspected site of active infection
  • Inflammatory bowel disease or malabsorption defined with steatorrhea
  • Active gastrointestinal bleeding, defined as melena, hematochezia, or hematemesis requiring hospitalization within the last 30 days
  • Use of probenecid, valproate, or corticosteroids within the last 24 hours
  • Use of any medication, other than those approved by the Sponsor and Investigator, in the last 48 hours
  • History of seizures within the last 72 hours
  • Positive drugs of abuse urine test
  • Positive alcohol breath test
  • Donation or loss of blood (500 mL or more) within the last 30 days
  • Donation or loss of plasma within the last 7 days
  • History of acquired immunodeficiency syndrome (AIDS) or determined human immunodeficiency virus (HIV) positive
  • Hepatitis B or C (HBV; HCV) positive (healthy volunteers only)
  • Use of any investigational drug within the last 30 days
  • Known hypersensitivity to sodium phenylbutyrate or similar drugs
  • Emergency hospitalization within the last 90 days
  • Intake of alcohol in the last 7 days

Pre-dose (days 0 and 7):

  • Significant illness or emergency hospitalization since the last study visit
  • Oral temperature > 38.5°C or < 36°C and/or a suspected site of active infection
  • Use of probenecid, valproate, or corticosteroids within the last 24 hours
  • Use of any non-approved medication (by the Sponsor/Investigator) within the 48 hours before dosing
  • History of seizures within the last 72 hours
  • Positive drugs of abuse urine test
  • Positive alcohol breath test
  • Donation or loss of blood (500 mL or more) or plasma since the last study visit
  • Use of any investigational drug since the last study visit
  • Intake of alcohol in the last 7 days
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Ukraine
 
 
NCT00986895
UP 1204-002
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Horizon Pharma Ireland, Ltd., Dublin Ireland
Ucyclyd Pharma, Inc.
Principal Investigator: Igor Zupanets, MD National University of Pharmacy
Horizon Pharma Ireland, Ltd., Dublin Ireland
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP