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

ClinicalTrials.gov ID: NCT01597635

Public ClinicalTrials.gov record NCT01597635. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 26, 2026, 7:53 AM EDT

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Official title

A Two Part Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK2586881 in Patients With Acute Lung Injury

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT01597635
Recruitment status: Completed
Study type: Interventional
Phase: Phase 2
Lead sponsor: GlaxoSmithKline; Industry
Enrollment: 44 participants

Conditions and interventions

Conditions

Lung Injury, Acute

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years to 80 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Aug 31, 2012
Primary completion: Sep 30, 2014
Completion: Oct 5, 2014
Last update posted: Sep 27, 2017

2012 – 2014

United States locations

U.S. sites: 13
U.S. states: 10
U.S. cities: 12

Facility	City	State	ZIP	Site status
GSK Investigational Site	Sacramento	California	95817	—
GSK Investigational Site	Chicago	Illinois	60611	—
GSK Investigational Site	Springfield	Massachusetts	01199	—
GSK Investigational Site	Ann Arbor	Michigan	48109	—
GSK Investigational Site	New York	New York	10003	—
GSK Investigational Site	Durham	North Carolina	27710	—
GSK Investigational Site	Greensboro	North Carolina	27403	—
GSK Investigational Site	Winston-Salem	North Carolina	27517	—
GSK Investigational Site	Columbus	Ohio	43215	—
GSK Investigational Site	Portland	Oregon	97239	—
GSK Investigational Site	Philadelphia	Pennsylvania	19104	—
GSK Investigational Site	Philadelphia	Pennsylvania	19107	—
GSK Investigational Site	Charleston	South Carolina	29425	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 6 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01597635, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Sep 27, 2017 · Synced Sep 26, 2026

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The complete protocol, eligibility criteria, and contact information for NCT01597635 live on ClinicalTrials.gov.

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