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

This study is currently recruiting participants.

Verified by AstraZeneca, August 2009

First Received: March 11, 2009 Last Updated: August 18, 2009 History of Changes

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00860821

Purpose

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)

Condition	Intervention
Healthy	Drug: AZD8309

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Pharmacodynamics Study
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).

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Neutrophil numbers in nasal lavage [ Time Frame: 3 times each in the end of two treatment periods ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Cells and inflammatory biomarkers in nasal lavage [ Time Frame: 3 times in the end of the two treatment periods ] [ Designated as safety issue: No ]
Cells and inflammatory biomarkers in blood [ Time Frame: 2 times in the beginning and 5 times in the end of the two treatment periods ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	March 2009
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental AZD8309	Drug: AZD8309 oral solution 30 mg/g, dose: 300mg bid for 3 days
2: Placebo Comparator Placebo	Drug: AZD8309 oral solution 30 mg/g, dose: 300mg bid for 3 days

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00860821

Contacts

Contact: Malin Fageras

46 46 336000

D1511M00004@astrazeneca.com

Locations

Sweden
Research Site	Recruiting
Malmö, Sweden

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:	Lars Olaf Cardell	Department of Otorhinolaryngology, Malmö University Hospital, Sweden
Study Director:	Leif Eriksson	AstraZeneca R&D Lund, Sweden

More Information

No publications provided

Responsible Party:	AstraZeneca R&D Lund ( Leif Eriksson, MD PhD, Medical Science Director, RITA CPT2 )
Study ID Numbers:	D1511M00004
Study First Received:	March 11, 2009
Last Updated:	August 18, 2009
ClinicalTrials.gov Identifier:	NCT00860821 History of Changes
Health Authority:	Sweden: Medical Products Agency

Keywords provided by AstraZeneca:

Healthy subjects
LPS
Effect
Intranasally

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on September 10, 2009