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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002387-12 | EudraCT Number |
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To evaluate the effect of idalopirdine (120 and 360 mg) on cardiac repolarisation in healthy men.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Idalopirdine 120 mg | Experimental | Therapeutic dosages |
|
| Idalopirdine 360 mg | Experimental | Supra-therapeutic dosages |
|
| Moxifloxacin 400 mg | Active Comparator | Positive Control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Capsules, orally, single dose |
| |
| ldalopirdine 120 mg |
| Measure | Description | Time Frame |
|---|---|---|
| Change from pre-dose baseline in the QT interval (ΔQTcF) at each post-dose time point within the ECG collection period | The QT interval will be corrected for heart rate by using the Fridericia's method (QTcF) | For 24 hours in each dosing period |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion and exclusion criteria do apply
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| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@Lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FR801 | Rennes | France |
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| ID | Term |
|---|---|
| C568612 | (2-(6-fluoro-1H-indol-3-yl)-ethyl)-(3-(2,2,3,3-tetrafluoropropoxy)benzyl)amine |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Drug |
Two 60 mg encapsulated film-coated tablets, orally, single dose |
|
| Idalopirdine 360 mg | Drug | Four 90 mg encapsulated film-coated tablets, orally, single dose |
|
| Moxifloxacin 400 mg | Drug | Encapsulated tablets, orally, single dose |
|
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |