- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00963183
AZD5423 Single Ascending Dose Study
January 13, 2015 updated by: AstraZeneca
A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Inhaled AZD5423 After Single Ascending Doses in Healthy Male Subjects
The aim of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD5423 following single ascending dose administrations in healthy male subjects.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
72
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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London, United Kingdom
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Provision of signed, written and dated informed consent prior to any study specific procedures
- Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
Exclusion Criteria:
- Any clinically significant disease or disorder
- Any clinically significant abnormalities at screening examination
- Use of any prescribed or non-prescribed medication
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A
Drug: AZD5423
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Solution for nebulisation, inhaled.
Each subject will receive a single-dose of AZD5423 or placebo.
Starting dose 8.4µg (lung deposited dose) with up to 8 dose escalations not exceeding AstraZeneca pre-defined exposure limits.
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Placebo Comparator: B
Drug: Placebo
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Solution for nebulisation, inhaled.
Each subject will receive a single-dose.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab), lung function and physical examination
Time Frame: Frequent sampling occasions during study days
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Frequent sampling occasions during study days
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacokinetics - Maximum plasma concentration (Cmax), time to Cmax (tmax), area under the plasma concentration-time curve from zero to the time of the last measurable concentration [AUC(0-t)] and from zero to infinity (AUC)
Time Frame: Frequent sampling occasions during study days
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Frequent sampling occasions during study days
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Add'l pharmacokinetics - Terminal rate constant (λz); terminal half-life (t½λz), Apparent plasma clearance (CL/F), apparent volume of distribution during terminal phase (Vz/F), mean residence time (MRT).
Time Frame: Frequent sampling occasions during study days
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Frequent sampling occasions during study days
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Pharmacodynamics - Plasma cortisol concentrations
Time Frame: Frequent sampling occasions during study days
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Frequent sampling occasions during study days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Jorup Carin, AstraZeneca R&D, Lund, Sweden
- Principal Investigator: Darren Wilbraham, Guy's Drug Research Unit, Quintiles Ltd, London, UK
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2009
Primary Completion (Actual)
November 1, 2009
Study Completion (Actual)
November 1, 2009
Study Registration Dates
First Submitted
August 17, 2009
First Submitted That Met QC Criteria
August 20, 2009
First Posted (Estimate)
August 21, 2009
Study Record Updates
Last Update Posted (Estimate)
January 14, 2015
Last Update Submitted That Met QC Criteria
January 13, 2015
Last Verified
November 1, 2014
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- D2340C00001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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