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| ID | Type | Description | Link |
|---|---|---|---|
| EUdract NO 2007-004859-11 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Escalating doses of AZD3480 during 6 days |
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| 2 | Experimental | Repeated doses of AZD3480 during 6 days |
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| 3 | Placebo Comparator | Placebo during 6 days |
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| 4 | Active Comparator | Placebo during 5 days, active day 6 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD3480 | Drug | Capsule, oral, single dose, 6 days |
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| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hans-Göran Hårdemark | Clinical Neuroscience TA AstraZeneca R&D Södertälje, Sweden | Study Director |
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| ID | Term |
|---|---|
| C490152 | ispronicline |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Moxifloxacin | Drug | Capsule(encapsulated), oral, single dose |
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| PLACEBO | Drug | Capsule, oral, single dose |
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| Registration of AEs, blood pressure, ECG, clinical laboratory tests | From enrolment to follow-up |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |