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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Drug: placebo; Drug: AZD5672; Drug: Moxifloxacin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00887770

Eudract No. 2009-009940-22

D1710C00006

Details and patient eligibility

About

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.

Enrollment: 64 estimated patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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64 participants in 4 patient groups, including a placebo group

A

Experimental group

Description:

600mg AZD5672 + Moxifloxacin placebo

Treatment:

Drug: placebo

Drug: placebo

Drug: placebo

Drug: AZD5672

Drug: AZD5672

B

Experimental group

Description:

100mg AZD5672 + Moxifloxacin placebo

Treatment:

Drug: placebo

Drug: placebo

Drug: placebo

Drug: AZD5672

Drug: AZD5672

C

Active Comparator group

Description:

AZD5672 placebo + Moxifloxacin 400mg

Treatment:

Drug: placebo

Drug: placebo

Drug: Moxifloxacin

Drug: placebo

D

Placebo Comparator group

Description:

AZD5672 placebo + Moxifloxacin placebo

Treatment:

Drug: placebo

Drug: placebo

Drug: placebo