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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.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00860821
First received: March 11, 2009
Last updated: October 27, 2009
Last verified: October 2009
History of Changes
  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: 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
AZD8309
 Drug: AZD8309
oral solution 30 mg/g, dose: 300mg bid for 3 days
Placebo Comparator: 2
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

Locations
Sweden
Research Site
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: Leif Eriksson, MD PhD, Medical Science Director, RITA CPT2, AstraZeneca R&D Lund
ClinicalTrials.gov 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
LPS
Effect
Intranasally

ClinicalTrials.gov processed this record on May 23, 2013