A Study to Investigate the Potential for AZD5672 to Affect the Electrical Conduction Pathways in the Heart

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00887770

Enrollment

Registered

2009-04-24

Start date

2009-04-30

Completion date

2009-07-31

Last updated

2009-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

QTcF, Crossover, ICH E14, QT/QTc prolongation, Moxifloxacin, QT/QTc Interval

Brief summary

This study is being performed to investigate the potential for AZD5672 to affect the electrical conduction pathways in the heart. AZD5672 will be compared against a drug (moxifloxacin - a licensed antibiotic) known to have a detectable but safe change on the electrical conduction of the heart.

Interventions

DRUGAZD5672

12 x 50mg tablet, oral, single dose

DRUGMoxifloxacin

1 x 400mg capsule, oral, single dose

DRUGplacebo

12 x matched to AZD5672 50 mg tablet

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Body Mass Index (BMI) between 18 and 30 kg/m2 and a minimum weight of 50kg. * Non-smoker

Exclusion criteria

* Marked QTc prolongation at baseline e.g. repeated demonstration of QTc interval \>450ms or marked shortening of QTcF \<350ms * Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of the QTc Interval changes * Use of concomitant medications that prolong QT/QTc interval

Design outcomes

Primary

Measure	Time frame
Evaluate time-matched QTcF intervals of single dose AZD5672 600mg compared to placebo.	Up to 24 hours postdose

Secondary

Measure	Time frame
Evaluate time-matched QTcF Intervals of single dose AZD5672 150mg compared to placebo.	Up to 24 hours postdose
To evaluate the change in time matched ECG parameters (QTcB, QTcX, RR, PR and QRS) of single dose AZD5672 600mg and 150mg compared to placebo	Up to 24 hours postdose
To further evaluate the safety and tolerability of single dose AZD5672 600mg and 150mg	Adverse events assessed throughout the whole study. Safety monitoring (BP, safety blood samples and ECG) conducted frequently throughout study and up to 72 hours post dose on treatment visits.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026