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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
75
Capsule, oral, single dose, 6 days
Capsule(encapsulated), oral, single dose
Capsule, oral, single dose
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
Time frame: 11 dECG measurements x 4 (4-way crossover)
QTcX (therapeutic doses in comparison to placebo).PR-, QRS-, RR-intervals
Time frame: 11 dECG measurements x 4 (4-way crossover)
Plasma concentration (AUC, Cmax, tmax etc)
Time frame: 11 PK-measurements x 4 (4-way crossover)
Registration of AEs, blood pressure, ECG, clinical laboratory tests
Time frame: From enrolment to follow-up
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