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:

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Ozone

Genetic and Rare Diseases Information Center resources: Cystic Fibrosis

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)

Eligibility


Ages Eligible for Study:	18 Years to 50 Years (Adult)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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:


Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Cystic Fibrosis Respiratory Tract Diseases	Pancreatic Diseases Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on September 29, 2016

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