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
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
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
- 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.
- Lactating or pregnant females.
- Subjects with BP > 160/90.
Inclusion and exclusion 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)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
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
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Additional information
Results for study EMD10007 can be found on the GSK Clinical Study Register.
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