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The Safety, Tolerability, PK and PD of GSK2586881 in Patients With Acute Lung Injury

NCT01597635 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2017-09-28

Study results available
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Summary

This is an early phase (phase IIa), randomized, multi-center study in subjects with acute lung injury (ALI) or acute respiratory distress syndrome (ARDS). The purpose of this study is to investigate the safety of GSK2586881 and to determine what effects it has on people with Acute Lung Injury (ALI) or Acute Respiratory Distress Syndrome (ARDS).

The study has two parts: Part A will be an open-label investigation in five subjects. Part B will be a double-blind, placebo controlled investigation and will involve approximately 60 subjects.

Conditions

  • Lung Injury, Acute

Interventions

DRUG

Dose 1 GSK2586881

Low dose GSK2586881 administered intravenously

DRUG

Dose 2 GSK2586881

Medium dose GSK2586881 administered intravenously

DRUG

Dose 3 GSK2586881

Medium-High dose GSK2586881 administered intravenously

DRUG

Dose 4 GSK2586881

High dose GSK2586881 administered intravenously

DRUG

Placebo (saline)

Administered intravenously to match intervention

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-01
Primary Completion
2014-10-01
Completion
2014-10-06

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01597635 on ClinicalTrials.gov