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Endotoxin Challenge Study For Healthy Men and Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00515268
First received: August 9, 2007
Last updated: March 15, 2012
Last verified: February 2011
History of Changes
  Purpose

The proposed study will examine the effect of pre-treatment with inhaled GSK256066 using a lung inflammation model induced by bronchoscopic instillation of bacterial endotoxin (lipopolysaccharide, LPS) in healthy volunteers.Data from this study will be used to support GSK256066 dose selection for future studies in COPD patients.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Healthy Subjects
 Drug: GSK256066
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Diagnostic
Official Title: A Double Blind, Placebo Controlled, Repeat Dose Study to Compare the Effectiveness of Two Doses of GSK256066 With Placebo in Reducing Lung Inflammation Following Segmental LPS Challenge in Healthy Volunteers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Absolute BAL neutrophils at 24 h post LPS exposure The total and differential cell count (absolute and percentage cell counts) in BAL at 24 h post LPS exposure [ Time Frame: 24 hours ]

Secondary Outcome Measures:
  • Vital signs, ECG, FEV1, Serum concentration of protein inflammatory biomarkers, BAL concentrations of protein inflammatory biomarkers BAL concentrations of GSK256066, Day 1,Day 7&DAY 8 [ Time Frame: Day 1,Day 7&DAY 8 ]

Estimated Enrollment: 36
Study Start Date: September 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: GSK256066
    Other Name: GSK256066
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy males and females (contraception restrictions),
  • 18-50yrs,
  • BMI 19-31kg/m2,
  • Non-smokers,
  • FEV1 >/= 80% predicted

Exclusion Criteria:

  • Abnormal troponin and/or CK MB,
  • Participated in any GSK study involving the administration of COA for >/= 21 days.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00515268

Locations
Germany
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30625
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00515268     History of Changes
Other Study ID Numbers: IPC103711
Study First Received: August 9, 2007
Last Updated: March 15, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by GlaxoSmithKline:
LPS challenge,
Healthy volunteers

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
 Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Lung Diseases, Obstructive

ClinicalTrials.gov processed this record on May 16, 2013