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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Sepsis

Treatments: Drug: Intravenous GR270773 - Phospholipid emulsion

Study type: Interventional

Funder types: Industry

Identifiers

NCT00158769

EMD10007

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Subjects with moderate hepatic impairment

Experimental group

Description:

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.

Treatment:

Drug: Intravenous GR270773 - Phospholipid emulsion

Healthy subjects

Experimental group

Description:

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.

Treatment:

Drug: Intravenous GR270773 - Phospholipid emulsion