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Completed

NCT Number: NCT00551811

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

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.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Berlin, 14050, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SB-656933-AAA

Drug

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

Placebo

Drug

Placebo tablets will be intended to be administered orally.

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Oct 31, 2007
Registry last updated
Aug 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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