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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005646-37 | EudraCT Number |
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To determine the absolute bioavailability of the Lu AE58054 tablet formulation at steady state
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lu AE58054 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lu AE58054 | Drug | Oral dosing: 90 mg Lu AE58054 as a single dose once and after a 3 days washout period, once daily for 7 days. Intravenous dosing: 90 μg/not more than (NMT) 1000 nCi/37 kBq 14C-Lu AE58054 for intravenous infusion once on Day 10. |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute bioavailability: (AUC0-24) Dose oral/(AUC0-inf) Dose IV | Intravenous (IV) | Day 10 |
| Ratio of (AUC0-24(PM)/AUC0-24(EM)) | Poor Metaboliser (PM); Extensive Metaboliser (EM) | Day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Number and frequency of adverse events | Standard clinical safety assessments | Up to Day 16 |
| Number of subjects with adverse events | Adverse event monitoring |
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Inclusion Criteria:
Exclusion Criteria:
Other inclusion and exclusion criteria may 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 |
|---|---|---|---|---|---|---|
| GB803 | Nottingham | NG11 6JS | United Kingdom |
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| ID | Term |
|---|---|
| C568612 | (2-(6-fluoro-1H-indol-3-yl)-ethyl)-(3-(2,2,3,3-tetrafluoropropoxy)benzyl)amine |
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| Up to Day 16 |
| Risk of Suicidality | Columbia Suicide Severity Rating Scale (C-SSRS) categorisation based on Columbia Classification Algorithm of Suicide Assessment (C-CASA) definitions | Up to Day 16 |