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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003597-27 | EudraCT Number |
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To examine the effect of the strong CYP3A4/5 inhibitor itraconazole (200 mg QD) on the multipledose exposure of Lu AE58054 (30 mg QD) in healthy subjects (CYP2D6 extensive metabolisers).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lu AE58054 30 mg + itraconazole 200 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lu AE58054 30 mg | Drug | Lu AE58054 encapsulated film-coated tablets, once daily, Day 1-5, orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the Lu AE58054 plasma concentration-time curve from time zero to 24 hours post-dose (AUC0-24) | Day 5 and Day 11 | |
| Maximum observed concentration (Cmax) of Lu AE58054 | Day 5 and Day 11 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma pharmacokinetics for Lu AE58054: AUC0-24, Cmax, time at which maximum observed plasma concentration occurred (tmax), apparent oral clearance (CL/F), half life (t½) and apparent volume of distribution Vz/F | Day 5 and Day 11 | |
| Plasma pharmacokinetics for relevant metabolites: AUC0-24, Cmax, tmax, t½ and metabolic ratio (MR) |
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Inclusion Criteria:
Subjects are eligible for inclusion into the study if they meet each of the following 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 |
|---|---|---|---|---|---|---|
| FR801 | Rennes | 35042 | France |
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| ID | Term |
|---|---|
| C568612 | (2-(6-fluoro-1H-indol-3-yl)-ethyl)-(3-(2,2,3,3-tetrafluoropropoxy)benzyl)amine |
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Lu AE58054 30 mg + itraconazole 200 mg | Drug | Lu AE58054 encapsulated film-coated tablets, once daily, Day 6-11, orally + itraconazole capsules, once daily, Day 6-11, orally |
|
| Itraconazole | Drug | Itraconazole capsules, once daily, Day 12-13, orally |
|
| Day 5 and Day 11 |
| Plasma pharmacokinetic parameters for itraconazole: CTrough | Day 6 to Day 13 |
| Adverse events | Up to Day 18, including a safety follow-up |
| Columbia Suicide Severity Rating Scale (C-SSRS) categorization based on Columbia Classification Algorithm of Suicide Assessment (C-CASA) definitions | Up to Day 18, including a safety follow-up |
| D010879 |
| Piperazines |