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Completed

NCT Number: NCT00860821

A Methodology Study in Healthy Subjects to Evaluate the Effect of AZD8309 After Nasal Administration of Lipopolysaccharide (LPS)

The purpose of this methodology study is to evaluate the effect of AZD8309 on cells and inflammatory biomarkers in nasal lavage and blood after nasal challenge with lipopolysaccharide (LPS)

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Research Site

Malmö, Sweden

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy men or healthy, permanently sterilized, women aged 18 to 50 years inclusive, non-smokers or ex-smokers, Body Mass Index 18 to 30 kg/m2 and minimum body weight of 50 kg
  • Blood neutrophil count above 2.2x10^9/L

Exclusion criteria

  • Clinical relevant disease and/or abnormality

Treatment and study plan

AZD8309

Drug

oral solution 30 mg/g, dose: 300mg bid for 3 days

Primary outcomes

  1. Neutrophil numbers in nasal lavage

    Time frame: 3 times each in the end of two treatment periods

Secondary outcomes

  1. Cells and inflammatory biomarkers in nasal lavage

    Time frame: 3 times in the end of the two treatment periods

  2. Cells and inflammatory biomarkers in blood

    Time frame: 2 times in the beginning and 5 times in the end of the two treatment periods

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Randomised, Double-blind, Placebo-controlled, Two-way Crossover, Single-centre Methodologhy Study in Healthy Subjects to Evaluate the Effect of Oral Dosing With AZD8309 on Cells and Inflammatory Biomarkers in Nasal Lavage and Blood After Nasal Challenge With Lipopolysaccharide (LPS).

Important dates

Study start
2009
Study completion
2009
First posted
Mar 12, 2009
Registry last updated
Oct 28, 2009

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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