A Study To Compare The Effects Of The Infusion Of A Sepsis Drug Between Healthy Adults And Adults With Damaged Livers
Phase 1
Completed
- Conditions
- Sepsis
- Interventions
- Drug: Intravenous GR270773 - Phospholipid emulsion
- Registration Number
- NCT00158769
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Subjects with moderate hepatic impairment Intravenous GR270773 - Phospholipid emulsion 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. Healthy subjects Intravenous GR270773 - Phospholipid emulsion 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.
- Primary Outcome Measures
Name Time Method 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. Up to Day 16
- Secondary Outcome Measures
Name Time Method 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. Up to Day 16
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of GR270773 in modulating lipid metabolism for sepsis treatment?
How does hepatic impairment affect the pharmacokinetics of GR270773 phospholipid emulsion in phase 1 trials?
What comparative effectiveness data exists for GR270773 versus standard-of-care sepsis therapies in clinical trials?
Which biomarkers correlate with GR270773 efficacy in septic patients with varying degrees of liver function?
What adverse event profiles have been reported for lipid-based sepsis drugs like GR270773 in phase 1 studies?
Trial Locations
- Locations (1)
GSK Investigational Site
🇸🇰Bratislava, Slovakia
GSK Investigational Site🇸🇰Bratislava, Slovakia