NCT00158769

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1 sepsis

Timeline
Completed

Started Mar 2005

Shorter than P25 for phase_1 sepsis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 31, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2005

Completed
Last Updated

September 25, 2017

Status Verified

September 1, 2017

Enrollment Period

7 months

First QC Date

September 8, 2005

Last Update Submit

September 20, 2017

Conditions

Sepsis

Keywords

Hepatic ImpairmentGR270773Emulsion

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (2)

Subjects with moderate hepatic impairment

EXPERIMENTAL

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.

Drug: Intravenous GR270773 - Phospholipid emulsion

Healthy subjects

EXPERIMENTAL

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.

Drug: Intravenous GR270773 - Phospholipid emulsion

Interventions

Intravenous GR270773 - Phospholipid emulsionDRUG

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

Healthy subjectsSubjects with moderate hepatic impairment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Bratislava, 833 05, Slovakia

Location

Related Links

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

March 31, 2005

Primary Completion

October 26, 2005

Study Completion

October 26, 2005

Last Updated

September 25, 2017

Record last verified: 2017-09

Locations

SL(1)