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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE October 29, 2007
First Posted Date  ICMJE October 31, 2007
Last Update Posted Date August 7, 2017
Actual Study Start Date  ICMJE October 8, 2007
Actual Primary Completion Date July 22, 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2007)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2007)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluate the Effects of the Drug (SB-656933-AAA) on the Body After a Single Dose in Subjects Who Have Inhaled Ozone
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
Condition  ICMJE Pulmonary Disease, Chronic Obstructive
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: SB-656933-AAA
    • Drug: Placebo
  • 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.
    Interventions:
    • Drug: SB-656933-AAA
    • Drug: Placebo
  • 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.
    Interventions:
    • Drug: SB-656933-AAA
    • Drug: Placebo
Publications * Lazaar AL, Sweeney LE, MacDonald AJ, Alexis NE, Chen C, Tal-Singer R. SB-656933, a novel CXCR2 selective antagonist, inhibits ex vivo neutrophil activation and ozone-induced airway inflammation in humans. Br J Clin Pharmacol. 2011 Aug;72(2):282-93. doi: 10.1111/j.1365-2125.2011.03968.x.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 4, 2017)
23
Original Estimated Enrollment  ICMJE
 (submitted: October 29, 2007)
24
Actual Study Completion Date  ICMJE July 22, 2008
Actual Primary Completion Date July 22, 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT00551811
Other Study ID Numbers  ICMJE CR2100597
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party GlaxoSmithKline
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE GlaxoSmithKline
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP