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Evaluate the Effects of the Drug (SB-656933-AAA) on the Body After a Single Dose in Subjects Who Have Inhaled Ozone.

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00551811
First received: October 29, 2007
Last updated: October 14, 2010
Last verified: October 2010
History of Changes
  Purpose

A study to evaluate the effect of SB-656933-AAA on the body after a single dose in subjects who have been challenged with ozone.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
Cystic Fibrosis
 Drug: SB-656933-AAA
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo Controlled, 3-way Crossover Study to Evaluate the Pharmacodynamics of SB-656933-AAA Following Single Doses in Healthy Adult Subjects Undergoing Ozone Challenge.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • To assess the effect of a single dose of SB-656933-AAA on ozone-induced inflammation in healthy subjects. Total number of neutrophils in sputum 6 hours after inhaling ozone. [ Time Frame: 6 hours after inhaling ozone ]

Secondary Outcome Measures:
  • Total number of white cells in sputum 6 hours after inhaling ozone. Concentration of protein in sputum. Safety of SB-656933-AAA. [ Time Frame: 6 hours after inhaling ozone ]

Estimated Enrollment: 24
Study Start Date: October 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: SB-656933-AAA
    Other Name: SB-656933-AAA
  Eligibility

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

Inclusion Criteria:

  • Healthy subjects between 18-50 years.
  • Females should be of non-child bearing potential.
  • Non-smoking for at least 12 months.
  • Normal lung function.
  • Subjects should be able to produce acceptable sputum samples.

Exclusion Criteria:

  • Any serious medical condition.
  • Hepatitis B or C and/or HIV positive.
  • Currently on regular medication except paracetamol.
  • Body Mass Index <20 or >30.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00551811

Locations
Germany
GSK Investigational Site
Berlin, Germany, 14050
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00551811     History of Changes
Other Study ID Numbers: CR2100597
Study First Received: October 29, 2007
Last Updated: October 14, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by GlaxoSmithKline:
SB-656933-AAA,
single dose,
ozone challenge

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
 Pancreatic Diseases
Digestive System Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013