Status:
COMPLETED
A Study To Compare The Effects Of The Infusion Of A Sepsis Drug Between Healthy Adults And Adults With Damaged Livers
Lead Sponsor:
GlaxoSmithKline
Conditions:
Sepsis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 peo...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 31 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 26 2005
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00158769
Start Date
March 31 2005
End Date
October 26 2005
Last Update
September 25 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
GSK Investigational Site
Bratislava, Slovakia, 833 05