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

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: March 11, 2009
Last updated: October 27, 2009
Last verified: October 2009
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
Drug: AZD8309

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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
Study Completion Date: October 2009
Arms Assigned Interventions
Experimental: 1
Drug: AZD8309
oral solution 30 mg/g, dose: 300mg bid for 3 days
Placebo Comparator: 2
Drug: AZD8309
oral solution 30 mg/g, dose: 300mg bid for 3 days


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00860821

Research Site
Malmö, Sweden
Sponsors and Collaborators
Principal Investigator: Lars Olaf Cardell Department of Otorhinolaryngology, Malmö University Hospital, Sweden
Study Director: Leif Eriksson AstraZeneca R&D Lund, Sweden
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Leif Eriksson, MD PhD, Medical Science Director, RITA CPT2, AstraZeneca R&D Lund Identifier: NCT00860821     History of Changes
Other Study ID Numbers: D1511M00004 
Study First Received: March 11, 2009
Last Updated: October 27, 2009
Health Authority: Sweden: Medical Products Agency

Keywords provided by AstraZeneca:
Healthy subjects
Intranasally processed this record on October 21, 2016