Investigate the Effect on the QT/QTc Interval of Repeated and Escalating Doses of AZD3480 During 6 Days

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effects on cardiac repolarisation of supratherapeutic doses of AZD3480 compared to placebo in healthy male volunteers, subgrouped as extensive metabolisers and poor metabolisers according to CYP2D6 metabolic capacity, using moxifloxacin as positive control.

Official Title
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A Double-Blind, Randomised, Multicentre, Placebo-Controlled, 4-Ways Crossover Study to Investigate the Effect on the QT/QTc Interval of Repeated and Escalating Doses of AZD3480 During 6 Days, Using Moxifloxacin as a Positive Control, in Healthy Male Volunteers, CYP2D6 Extensive and Poor Metabolisers.

Conditions
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Healthy

Intervention / Treatment
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* Drug: AZD3480
* Drug: Moxifloxacin
* Drug: PLACEBO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participation in a previous study for genotyping for identification to be extensive or poor metaboliser (CYP2D6 enzyme) Physically and mentally healthy male volunteers Exclusion Criteria: History of clinically significant diseases or illness. Participation in another study the last 3 months Prescribed or non-prescribed medications from 3 weeks prior to first treatment day until follow-up except for paracetamol (max 1.5 g per day.)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 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: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Escalating doses of AZD3480 during 6 days | Drug: AZD3480<br>* Capsule, oral, single dose, 6 days<br>* Other names: TC-1734-226;|
| Experimental: 2<br>Repeated doses of AZD3480 during 6 days | Drug: AZD3480<br>* Capsule, oral, single dose, 6 days<br>* Other names: TC-1734-226;|
| Placebo Comparator: 3<br>Placebo during 6 days | Drug: PLACEBO<br>* Capsule, oral, single dose<br>|
| Active Comparator: 4<br>Placebo during 5 days, active day 6 | Drug: Moxifloxacin<br>* Capsule(encapsulated), oral, single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QTcX interval (supratherapeutic doses in comparison to placebo).Subject-specific correction of QT, QTcF and QTcB (supportive outcome variables).Bazett QTcB=QT*RR-1/2Fridericia QTcF=QT'RR-1/3 |  | 11 dECG measurements x 4 (4-way crossover) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QTcX (therapeutic doses in comparison to placebo).PR-, QRS-, RR-intervals |  | 11 dECG measurements x 4 (4-way crossover) | 
| Plasma concentration (AUC, Cmax, tmax etc) |  | 11 PK-measurements x 4 (4-way crossover) | 
| Registration of AEs, blood pressure, ECG, clinical laboratory tests |  | From enrolment to follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TQT, ECG, QT, QTc, AZD3480, ECG(QTc effects)