To evaluate the effect of AZD3199 on the electrical activity in the heart

Study identifier:D0570C00004

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A single-centre, randomised, double-blind, double-dummy, placebo controlled, 4-way crossover Phase I study to investigate the effect of 2 single doses (400 μg and 1200 µg) of inhaled AZD3199 on QT/QTc interval, compared to placebo, using moxifloxacin (Avelox®) as a positive control, in healthy male volunteers

Medical condition

Chronic Obstructive Pulmonary Disease

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD3199, Moxifloxacin

Sex

Male

Actual Enrollment

Study type

Interventional

Age

18 Years - 45 Years

Date

Study Start Date: 01 Nov 2010

Primary Completion Date: 01 Feb 2011

Study Completion Date: 01 Feb 2011

Study design

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Basic Science

Verification:

Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Location

Research Site

LONDON, UK, United Kingdom

Arms	Assigned Interventions
Experimental: 1 400 µg AZD3199 + moxifloxacin placebo	Drug: AZD3199 Single dose, oral inhalation
Experimental: 2 1200 µg AZD3199 + moxifloxacin placebo	Drug: AZD3199 Single dose, oral inhalation
Active Comparator: 3 AZD3199 placebo + moxifloxacin 400 mg	Drug: Moxifloxacin Single dose, oral encapsulated tablet Other Name: Avelox®
Placebo Comparator: 4 AZD3199 placebo + moxifloxacin placebo	Other: Placebo comparator Single dose, oral inhalation

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1663&filename=CSR-D0570C00004.pdf
Download
CSR-D0570C00004.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information

001-800-236-9933

information.center@astrazeneca.com

Investigators

Principal Investigator

Carin Jorup

AstraZeneca R&D, Lund, Sweden