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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:
ClinicalTrials.gov Identifier:
NCT00158769
First Posted: September 12, 2005
Last Update Posted: September 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  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 Drug: Intravenous GR270773 - Phospholipid emulsion Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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. [ Time Frame: Up to Day 16 ]

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. [ Time Frame: Up to Day 16 ]

Enrollment: 16
Actual Study Start Date: March 31, 2005
Study Completion Date: October 26, 2005
Primary Completion Date: October 26, 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Subjects with moderate hepatic impairment
Subjects with moderate hepatic impairment as defined by a Child-Pugh score of 7-9 will be included. Subjects will be given GR270773 as a loading infusion of 25 milligram per kilogram per hour (mg/kg/hr) for 2 hours followed by a maintenance infusion of 5 mg/kg/hr for 70 hours.
Drug: Intravenous GR270773 - Phospholipid emulsion
GR270773 (lipid emulsion) is a sterile, white to off-white, semi-translucent liquid for intravenous injection.
Experimental: Healthy subjects
Subjects will be matched as closely as possible to the group of moderate hepatic subjects for gender, age and body mass index (BMI). Subjects will be administered 25 mg/kg/hr GR270773 as a loading dose for 2 hours followed by a maintenance infusion of 5 mg/kg/hr for 70 hours. Following a washout period of 21 days, the subjects will then receive a loading dose of 75 mg/kg/hr for 2 hours followed by a maintenance dose of 12.5 mg/kg/hr of GR270773 for 70 hours.
Drug: Intravenous GR270773 - Phospholipid emulsion
GR270773 (lipid emulsion) is a sterile, white to off-white, semi-translucent liquid for intravenous injection.

  Eligibility

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00158769


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

Additional Information:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00158769     History of Changes
Other Study ID Numbers: EMD10007
First Submitted: September 8, 2005
First Posted: September 12, 2005
Last Update Posted: September 22, 2017
Last Verified: September 2017

Keywords provided by GlaxoSmithKline:
Hepatic Impairment
GR270773
Emulsion

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