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A Study To Compare The Effects Of The Infusion Of A Sepsis Drug Between Healthy Adults And Adults With Damaged Livers

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00158769
First received: September 8, 2005
Last updated: October 15, 2008
Last verified: October 2008
  Purpose

This compound, GR270773, is a lipid based compound being developed to treat Sepsis. Lipids are broken down in the body by the liver. This study is designed to see whether the effect of the drug in people with poorly functioning livers is any different to the effect on healthy adults.


Condition Intervention Phase
Sepsis
Septic Shock
Drug: Intravenous GR270773 - Phospholipid emulsion
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Non-Randomised, Pharmacokinetic, Metabolic Disposition and Safety Study of a 3 Day Continuous Infusion of GR270773 in Healthy Subjects and Subjects With Hepatic Impairment.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Compare drug concentrations in the blood between patients with impaired liver function and normal healthy adults, after 72 hours. Determine whether administration of study drug alters the lipid make-up of healthy adults in any way.

Secondary Outcome Measures:
  • Determine drug concentrations in blood after 2 hour run-in period and after 72 hour infusion period. Determine whether administration of study drug alters the lipid make-up of patients with impaired liver function in any way.

Estimated Enrollment: 16
Study Start Date: March 2005
Intervention Details:
    Drug: Intravenous GR270773 - Phospholipid emulsion
    Other Name: Intravenous GR270773 - Phospholipid emulsion
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Patients with known history of liver disease (either with or without history of alcohol abuse).
  • Previous confirmation of liver cirrhosis by liver biopsy or other medical imaging technique.
  • Child-Pugh score of 7-9 (moderate impairment) BMI 19-29 Kg/m2.
  • Healthy volunteers to match the hepatically impaired subjects in a 1:1 ratio by gender, age, BMI.

Exclusion criteria:

  • Lactating or pregnant females.
  • Subjects with BP > 160/90.
  • Subjects who, within the past six months, have had a history of significant drug or alcohol abuse, or any indication of regular use of more than 14 units of alcohol per week for women, or 21 units/week for men.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00158769

Locations
Slovakia
GSK Investigational Site
Bratislava, Slovakia, 833 05
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD, MPH GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00158769     History of Changes
Other Study ID Numbers: EMD10007
Study First Received: September 8, 2005
Last Updated: October 15, 2008
Health Authority: United States: Food and Drug Administration
Slovakia: State Institute for Drug Control

Keywords provided by GlaxoSmithKline:
Hepatic Impairment
Emulsion
GR270773

Additional relevant MeSH terms:
Sepsis
Shock, Septic
Infection
Inflammation
Pathologic Processes
Shock
Systemic Inflammatory Response Syndrome

ClinicalTrials.gov processed this record on November 20, 2014