Back to resultsEvaluate the Effects of the Drug (SB-656933-AAA) on the Body After a Single Dose in Subjects Who Have Inhaled Ozone
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
SB-656933-AAA
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring SB-656933-AAA,, ozone challenge, single dose,
Eligibility 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.
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Subjects receiving treatment sequence 1
Subjects receiving treatment sequence 2
Subjects receiving treatment sequence 3
Arm Description
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.
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.
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.
Outcomes
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00551811
Brief Title
Evaluate the Effects of the Drug (SB-656933-AAA) on the Body After a Single Dose in Subjects Who Have Inhaled Ozone
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
October 8, 2007 (Actual)
Primary Completion Date
July 22, 2008 (Actual)
Study Completion Date
July 22, 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
SB-656933-AAA,, ozone challenge, single dose,
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Subjects receiving treatment sequence 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Subjects receiving treatment sequence 2
Arm Type
Experimental
Arm Description
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.
Arm Title
Subjects receiving treatment sequence 3
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
SB-656933-AAA
Intervention Description
SB-656933-AAA tablets will be available with a dose strength of 50 milligrams, administered orally.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets will be intended to be administered orally.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
14050
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
21426372
Citation
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.
Results Reference
background
Learn more about this trial
Evaluate the Effects of the Drug (SB-656933-AAA) on the Body After a Single Dose in Subjects Who Have Inhaled Ozone
We'll reach out to this number within 24 hrs