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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2009-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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A

600mg AZD5672 + Moxifloxacin placebo

Group Type EXPERIMENTAL

AZD5672

Intervention Type DRUG

12 x 50mg tablet, oral, single dose

placebo

Intervention Type DRUG

1 x matched to Moxifloxacin capsule

B

100mg AZD5672 + Moxifloxacin placebo

Group Type EXPERIMENTAL

AZD5672

Intervention Type DRUG

3 x 50mg tablet, oral. single dose

placebo

Intervention Type DRUG

9 x matched to AZD5672 50mg tablet

placebo

Intervention Type DRUG

1 x matched to Moxifloxacin capsule

C

AZD5672 placebo + Moxifloxacin 400mg

Group Type ACTIVE_COMPARATOR

Moxifloxacin

Intervention Type DRUG

1 x 400mg capsule, oral, single dose

placebo

Intervention Type DRUG

12 x matched to AZD5672 50 mg tablet

D

AZD5672 placebo + Moxifloxacin placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

12 x matched to AZD5672 50 mg tablet

placebo

Intervention Type DRUG

1 x matched to Moxifloxacin capsule

Interventions

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AZD5672

12 x 50mg tablet, oral, single dose

Intervention Type DRUG

Moxifloxacin

1 x 400mg capsule, oral, single dose

Intervention Type DRUG

placebo

12 x matched to AZD5672 50 mg tablet

Intervention Type DRUG

AZD5672

3 x 50mg tablet, oral. single dose

Intervention Type DRUG

placebo

9 x matched to AZD5672 50mg tablet

Intervention Type DRUG

placebo

1 x matched to Moxifloxacin capsule

Intervention Type DRUG

Other Intervention Names

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Avelox

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes