A study to investigate the potential for AZD5672 to affect the electrical conduction pathways in the heart

Study identifier:D1710C00006

ClinicalTrials.gov identifier:NCT00887770

EudraCT identifier:2009-011044-20

CTIS identifier:N/A

Study Complete

Official Title

A Single-centre, Double-blind, Double-dummy, Randomised, Placebo-controlled, Four-period Crossover Study to Assess the Effect of Single Oral Doses of AZD5672 (600 mg and 150 mg) on QT/QTc Interval, Compared to Placebo, using Moxifloxacin (Avelox®) as a Positive Control, in Healthy Male Volunteers

Medical condition

Rheumatoid Arthritis

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD5672, Moxifloxacin, placebo

Sex

Male

Actual Enrollment

Study type

Interventional

Age

18 Years - 45 Years

Date

Study Start Date: 01 Apr 2009

Primary Completion Date: -

Study Completion Date: 01 Jul 2009

Study design

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

Verification:

Verified 01 Jun 2025 by AstraZeneca Pharmaceuticals

Collaborators

Quintiles Limited

Inclusion and exclusion criteria

Location

Research Site

London, United Kingdom

Arms	Assigned Interventions
Experimental: A 600mg AZD5672 + Moxifloxacin placebo	Drug: AZD5672 12 x 50mg tablet, oral, single dose Drug: placebo 1 x matched to Moxifloxacin capsule
Experimental: B 100mg AZD5672 + Moxifloxacin placebo	Drug: AZD5672 3 x 50mg tablet, oral. single dose Drug: placebo 9 x matched to AZD5672 50mg tablet Drug: placebo 1 x matched to Moxifloxacin capsule
Active Comparator: C AZD5672 placebo + Moxifloxacin 400mg	Drug: Moxifloxacin 1 x 400mg capsule, oral, single dose Other Name: Avelox Drug: placebo 12 x matched to AZD5672 50 mg tablet
Placebo Comparator: D AZD5672 placebo + Moxifloxacin placebo	Drug: placebo 12 x matched to AZD5672 50 mg tablet Drug: placebo 1 x matched to Moxifloxacin capsule

"There is no result for the study"

Documents available

CSR Synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information

800-236-9933

information.center@astrazeneca.com

Contact Backup

Joanne McGrath

+44 (0) 207 910 7785

Joanne.McGrath@Quintiles.com]

Investigators

Principal Investigator

Mark Layton

AstraZeneca R&D, Alderley Park, UK