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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

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ClinicalTrials.gov Identifier: NCT00551811
Recruitment Status : Completed
First Posted : October 31, 2007
Last Update Posted : August 7, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Drug: SB-656933-AAA Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
Official Title: A Dose Ranging Study to Assess the Effect of Pre-treatment With a Single Dose of Oral SB656933 on Lung Inflammation Following Challenge With Inhaled Ozone and Intermittent Exercise in Healthy Volunteers, Relative to Placebo
Actual Study Start Date : October 8, 2007
Actual Primary Completion Date : July 22, 2008
Actual Study Completion Date : July 22, 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ozone

Arms and Interventions
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Arm Intervention/treatment
Experimental: Subjects receiving treatment sequence 1
Eligible subjects will receive single doses of placebo in period 1, SB-656933-AAA with a dose of 50 milligrams in period 2 and 150 milligrams in period 3.
 Drug: SB-656933-AAA
SB-656933-AAA tablets will be available with a dose strength of 50 milligrams, administered orally.

Drug: Placebo
Placebo tablets will be intended to be administered orally.
Experimental: Subjects receiving treatment sequence 2
Eligible subjects will receive single doses of SB-656933-AAA with a dose of 50 milligrams in period 1, placebo in period 2 and SB-656933-AAA 150 milligrams in period 3.
 Drug: SB-656933-AAA
SB-656933-AAA tablets will be available with a dose strength of 50 milligrams, administered orally.

Drug: Placebo
Placebo tablets will be intended to be administered orally.
Experimental: Subjects receiving treatment sequence 3
Eligible subjects will receive single doses of SB-656933-AAA with a dose of 50 milligrams in period 1, 150 milligrams in period 2 and placebo in period 3.
 Drug: SB-656933-AAA
SB-656933-AAA tablets will be available with a dose strength of 50 milligrams, administered orally.

Drug: Placebo
Placebo tablets will be intended to be administered orally.


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00551811


Locations
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Germany
GSK Investigational Site
Berlin, Germany, 14050
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Additional Information:
Results for study CR2100597 can be found on the GSK Clinical Study Register.  This link exits the ClinicalTrials.gov site

Publications:

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00551811     History of Changes
Other Study ID Numbers: CR2100597
First Posted: October 31, 2007    Key Record Dates
Last Update Posted: August 7, 2017
Last Verified: August 2017

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

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