AZD5423 Single Ascending Dose Study
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
1 other identifier
interventional
72
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy-volunteers
Started Aug 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 17, 2009
CompletedFirst Posted
Study publicly available on registry
August 21, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedJanuary 14, 2015
November 1, 2014
3 months
August 17, 2009
January 13, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab), lung function and physical examination
Frequent sampling occasions during study days
Secondary Outcomes (3)
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)
Frequent sampling occasions during study days
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).
Frequent sampling occasions during study days
Pharmacodynamics - Plasma cortisol concentrations
Frequent sampling occasions during study days
Study Arms (2)
A
EXPERIMENTALDrug: AZD5423
B
PLACEBO COMPARATORDrug: Placebo
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Any clinically significant disease or disorder
- Any clinically significant abnormalities at screening examination
- Use of any prescribed or non-prescribed medication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (1)
Research Site
London, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jorup Carin
AstraZeneca R&D, Lund, Sweden
- PRINCIPAL INVESTIGATOR
Darren Wilbraham
Guy's Drug Research Unit, Quintiles Ltd, London, UK
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2009
First Posted
August 21, 2009
Study Start
August 1, 2009
Primary Completion
November 1, 2009
Study Completion
November 1, 2009
Last Updated
January 14, 2015
Record last verified: 2014-11