AZD5423 Single Ascending Dose Study
This study has been completed.
Information provided by:
First received: August 17, 2009
Last updated: December 1, 2009
Last verified: December 2009
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 Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
|Official Title:||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|
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Pharmacodynamics - Plasma cortisol concentrations [ Time Frame: Frequent sampling occasions during study days ] [ Designated as safety issue: No ]
|Study Start Date:||August 2009|
|Study Completion Date:||November 2009|
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.
Placebo Comparator: B
Solution for nebulisation, inhaled. Each subject will receive a single-dose.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00963183
|London, United Kingdom|
Sponsors and Collaborators
|Study Director:||Jorup Carin||AstraZeneca R&D, Lund, Sweden|
|Principal Investigator:||Darren Wilbraham||Guy's Drug Research Unit, Quintiles Ltd, London, UK|