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

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

Collaborators

Inclusion and exclusion criteria

Location

Research Unit

London, United Kingdom, SE1 1YR

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

"There is no result for the study"

Documents available

CSR Synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information

001-8002369933

information.center@astrazeneca.com

Investigators

Principal Investigator

Darren Wilbraham

Quintiles Drug Research Unit at Guy’s Hospital