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

• Status: Completed
• Trial end date: 2005-10-26
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline

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.