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

Phase 1

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: SB-656933-AAA; Drug: Placebo

• Registration Number: NCT00551811
• Lead Sponsor: GlaxoSmithKline

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 available

Study Timeline

• Study Start: 2007-10-08
• Study First Submitted: 2007-10-29
• Study First Submitted QC: 2007-10-29
• Study First Posted: 2007-10-31
• Primary Completion: 2008-07-22
• Study Completion: 2008-07-22
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-04
• Last Update Posted: 2017-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Subjects receiving treatment sequence 2	Placebo	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.
Subjects receiving treatment sequence 1	SB-656933-AAA	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.
Subjects receiving treatment sequence 3	SB-656933-AAA	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.
Subjects receiving treatment sequence 1	Placebo	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.
Subjects receiving treatment sequence 3	Placebo	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.
Subjects receiving treatment sequence 2	SB-656933-AAA	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.

Primary Outcome Measures

Name	Time	Method
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.	6 hours after inhaling ozone

Secondary Outcome Measures

Name	Time	Method
Total number of white cells in sputum 6 hours after inhaling ozone. Concentration of protein in sputum. Safety of SB-656933-AAA.	6 hours after inhaling ozone

Trial Locations

Locations (1)

GSK Investigational Site; 🇩🇪 Berlin, Germany