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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Placebo; Drug: SB-656933-AAA

Study type: Interventional

Funder types: Industry

Identifiers

NCT00551811

CR2100597

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

23 participants in 3 patient groups

Subjects receiving treatment sequence 1

Experimental group

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.

Treatment:

Drug: SB-656933-AAA

Drug: Placebo

Subjects receiving treatment sequence 2

Experimental group

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.

Treatment:

Drug: SB-656933-AAA

Drug: Placebo

Subjects receiving treatment sequence 3

Experimental group

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.

Treatment:

Drug: SB-656933-AAA

Drug: Placebo