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

Study Timeline

• Study Start: 2005-03-31
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-11
• Study First Posted: 2005-09-12
• Primary Completion: 2005-10-26
• Study Completion: 2005-10-26
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-20
• Last Update Posted: 2017-09-25

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

Trial Locations

Locations (1)

GSK Investigational Site; 🇸🇰 Bratislava, Slovakia