A study in healthy subjects and mild asthmatics to investigate Pharmacokinetics of AZD5423 when administered in different ways
Study identifier:D2340C00008
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
An Open, Partly Randomised, Four-way Cross-over Study in Healthy Subjects and in Patients with Mild Allergic Asthma to Investigate the Bioavailability and Basic Pharmacokinetics of a Single Dose of AZD5423 when Administered Intravenously, Orally, Inhaled via SPIRA Nebuliser or Inhaled via I-neb® AAD Systems
Medical condition
Healthy, asthma
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD5423
Sex
Male
Actual Enrollment
12
Study type
Interventional
Age
18 Years - 45 Years
Date
Study Start Date: 01 Apr 2011
Primary Completion Date: 01 Oct 2011
Study Completion Date: 01 Oct 2011
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verification:
Verified 01 Jan 2015 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 AZD5423 iv | Drug: AZD5423 solution for injection, administered as intravenous infusion Corr to total dose of 250µg AZD5423 |
| Experimental: 2 AZD5423 inhalation, Spira | Drug: AZD5423 nebuliser suspension, inhaled via Spira, corr to approximately 300 µg lung deposited dose AZD5423 |
| Experimental: 3 AZD5423 inhalation I-neb | Drug: AZD5423 nebuliser suspension, inhaled via I-neb, corr to approximately 300 µg lung deposited dose AZD5423 |
| Experimental: 4 AZD5423 oral | Drug: AZD5423 nebuliser suspension to be administered orally, corr to a total dose of 1200 µg AZD5423 |
Contacts
Investigators
Principal Investigator
Darren Wilbraham
Quintiles Drug Research Unit at Guy’s Hospital
