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NCT00860821 Clinical Trial

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

Healthy Clinical Trial

Official 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).

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00860821
Other study ID # D1511M00004
Secondary ID
Status Completed
Phase N/A
First received March 11, 2009
Last updated October 27, 2009
Start date March 2009
Est. completion date October 2009

Study information
Verified date October 2009
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Sweden: Medical Products Agency
Study type Interventional

Clinical Trial Summary

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)

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date October 2009
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 50 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Drug:
• AZD8309
oral solution 30 mg/g, dose: 300mg bid for 3 days
• AZD8309
oral solution 30 mg/g, dose: 300mg bid for 3 days

Locations
Country Name City State
Sweden Research Site Malmö

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Neutrophil numbers in nasal lavage 3 times each in the end of two treatment periods No
Secondary Cells and inflammatory biomarkers in nasal lavage 3 times in the end of the two treatment periods No
Secondary Cells and inflammatory biomarkers in blood 2 times in the beginning and 5 times in the end of the two treatment periods No
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