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

NCT ID: NCT00860821

Last Updated: 2009-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2009-10-31

Brief Summary

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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)

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

AZD8309

Group Type EXPERIMENTAL

AZD8309

Intervention Type DRUG

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

2

Placebo

Group Type PLACEBO_COMPARATOR

AZD8309

Intervention Type DRUG

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

Interventions

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AZD8309

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

Intervention Type DRUG

AZD8309

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca R&D Lund

Principal Investigators

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Lars Olaf Cardell

Role: PRINCIPAL_INVESTIGATOR

Department of Otorhinolaryngology, Malmö University Hospital, Sweden

Leif Eriksson

Role: STUDY_DIRECTOR

AstraZeneca R&D Lund, Sweden

Locations

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Research Site

Malmo, , Sweden

Site Status

Countries

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Sweden

References

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Leaker BR, Barnes PJ, O'Connor B. Inhibition of LPS-induced airway neutrophilic inflammation in healthy volunteers with an oral CXCR2 antagonist. Respir Res. 2013 Dec 16;14(1):137. doi: 10.1186/1465-9921-14-137.

Reference Type DERIVED
PMID: 24341382 (View on PubMed)

Other Identifiers

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D1511M00004

Identifier Type: -

Identifier Source: org_study_id

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