A Study in Healthy Subjects and Mild Asthmatics to Investigate Pharmacokinetics of AZD5423 When Administered in Different Ways
NCT ID: NCT01310322
Last Updated: 2015-01-14
Study Results
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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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2011-04-30
2011-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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1
AZD5423 iv
AZD5423
solution for injection, administered as intravenous infusion Corr to total dose of 250µg AZD5423
2
AZD5423 inhalation, Spira
AZD5423
nebuliser suspension, inhaled via Spira, corr to approximately 300 µg lung deposited dose AZD5423
3
AZD5423 inhalation I-neb
AZD5423
nebuliser suspension, inhaled via I-neb, corr to approximately 300 µg lung deposited dose AZD5423
4
AZD5423 oral
AZD5423
nebuliser suspension to be administered orally, corr to a total dose of 1200 µg AZD5423
Interventions
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AZD5423
solution for injection, administered as intravenous infusion Corr to total dose of 250µg AZD5423
AZD5423
nebuliser suspension, inhaled via Spira, corr to approximately 300 µg lung deposited dose AZD5423
AZD5423
nebuliser suspension, inhaled via I-neb, corr to approximately 300 µg lung deposited dose AZD5423
AZD5423
nebuliser suspension to be administered orally, corr to a total dose of 1200 µg AZD5423
Eligibility Criteria
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Inclusion Criteria
* Have a body mass index (BMI) between 18 and 30 kg/m2 (inclusive and rounding allowed) and weight between 50 and 100 kg (inclusive)
* Be able to inhale from the SPIRA nebuliser and I-neb® according to the provided instructions
* Asthma patients should fulfil the following criteria: Pre-bronchodilator forced expiratory volume at 1 second (FEV1) ≥70% of predicted normal value
* Asthma diagnosis according to GINA guidelines with a history of episodic wheeze and shortness of breath
Exclusion Criteria
* Any clinically relevant abnormal findings
* Current smokers
* Asthma patients: Worsening of asthma or respiratory infection within 6 weeks before screening
* Asthma patients: Use of inhaled, nasal, oral, rectal or parenteral corticosteroids within 30 days before first administration of investigational product and during the study
18 Years
45 Years
MALE
Yes
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Darren Wilbraham, Dr
Role: PRINCIPAL_INVESTIGATOR
Quintiles Drug Research Unit at Guy's Hospital
Locations
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Research Unit
London, , United Kingdom
Countries
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Related Links
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Other Identifiers
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D2340C00008
Identifier Type: -
Identifier Source: org_study_id
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