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

Study Overview
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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.

Official Title
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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

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: AZD5672
* Drug: Moxifloxacin
* Drug: placebo
* Drug: AZD5672
* Drug: placebo
* Drug: placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>600mg AZD5672 + Moxifloxacin placebo | Drug: AZD5672<br>* 12 x 50mg tablet, oral, single dose<br>Drug: placebo<br>* 1 x matched to Moxifloxacin capsule<br>|
| Experimental: B<br>100mg AZD5672 + Moxifloxacin placebo | Drug: AZD5672<br>* 3 x 50mg tablet, oral. single dose<br>Drug: placebo<br>* 9 x matched to AZD5672 50mg tablet<br>Drug: placebo<br>* 1 x matched to Moxifloxacin capsule<br>|
| Active Comparator: C<br>AZD5672 placebo + Moxifloxacin 400mg | Drug: Moxifloxacin<br>* 1 x 400mg capsule, oral, single dose<br>* Other names: Avelox;Drug: placebo<br>* 12 x matched to AZD5672 50 mg tablet<br>|
| Placebo Comparator: D<br>AZD5672 placebo + Moxifloxacin placebo | Drug: placebo<br>* 12 x matched to AZD5672 50 mg tablet<br>Drug: placebo<br>* 1 x matched to Moxifloxacin capsule<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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QTcF, Crossover, ICH E14, QT/QTc prolongation, Moxifloxacin, QT/QTc Interval