Last updated: 11/04/2018 06:36:46

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

GSK study ID
EMD10007
See study documents
Clinicaltrials.gov ID
NCT00158769
EudraCT ID
2004-002027-41
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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.
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

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.

Timeframe: Up to Day 16

Secondary outcomes:

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.

Timeframe: Up to Day 16

Interventions:
  • Drug: Intravenous GR270773 - Phospholipid emulsion
    • Enrollment:
    16
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Sepsis
    Product
    GR270773
    Collaborators
    Not applicable
    Study date(s)
    March 2005 to October 2005
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 65 years
    Accepts healthy volunteers
    Yes
    • Inclusion criteria:
    • Patients with known history of liver disease (either with or without history of alcohol abuse).
    Inclusion and exclusion criteria
    Inclusion 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Bratislava, Slovakia, 833 05
    Status
    Terminated/Withdrawn
    Contact us

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2005-26-10

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Participate in clinical trial
    Additional information
    Results for study EMD10007 can be found on the GSK Clinical Study Register.
    Click here
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