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

Sepsis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00158769
• Other study ID #: EMD10007
• Status: Completed
• Phase: Phase 1
• First received: September 8, 2005
• Last updated: September 20, 2017
• Start date: March 31, 2005
• Est. completion date: October 26, 2005

Study information

• Verified date: September 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 26, 2005
• Est. primary completion date: October 26, 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sepsis

Intervention

Drug:
• Intravenous GR270773 - Phospholipid emulsion
GR270773 (lipid emulsion) is a sterile, white to off-white, semi-translucent liquid for intravenous injection.

Locations

Country	Name	City	State
Slovakia	GSK Investigational Site	Bratislava

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   Results for study EMD10007 can be found on the GSK Clinical Study Register.