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

NCT ID: NCT00551811

Last Updated: 2017-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-08

Study Completion Date

2008-07-22

Brief Summary

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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

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Study Groups

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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.

Group Type EXPERIMENTAL

SB-656933-AAA

Intervention Type DRUG

SB-656933-AAA tablets will be available with a dose strength of 50 milligrams, administered orally.

Placebo

Intervention Type DRUG

Placebo tablets will be intended to be administered orally.

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.

Group Type EXPERIMENTAL

SB-656933-AAA

Intervention Type DRUG

SB-656933-AAA tablets will be available with a dose strength of 50 milligrams, administered orally.

Placebo

Intervention Type DRUG

Placebo tablets will be intended to be administered orally.

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.

Group Type EXPERIMENTAL

SB-656933-AAA

Intervention Type DRUG

SB-656933-AAA tablets will be available with a dose strength of 50 milligrams, administered orally.

Placebo

Intervention Type DRUG

Placebo tablets will be intended to be administered orally.

Interventions

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SB-656933-AAA

SB-656933-AAA tablets will be available with a dose strength of 50 milligrams, administered orally.

Intervention Type DRUG

Placebo

Placebo tablets will be intended to be administered orally.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Berlin, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 21426372 (View on PubMed)

Other Identifiers

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CR2100597

Identifier Type: -

Identifier Source: org_study_id

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