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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003870-28 | EudraCT Number |
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The purpose of this study is to evaluate the increase in exposure of Lu AF11167 following a single oral dose of Lu AF11167 with and without administration of multiple oral doses of itraconazole (a strong CYP3A4/5 inhibitor) in healthy subjects with inferred metabolic status as CYP2C19 extensive metabolisers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lu AF1167 capsule 0.5 mg | Experimental | Single oral dose (day 1) |
|
| Lu AF11167 0.5 mg capsule + itraconazole 200 mg capsule | Experimental | Itraconazole administered once daily for 7 days (day 3-9); Lu AF11167 administered as a single dose on day 8 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lu AF11167 | Drug |
| ||
| Itraconazole |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the Lu AF11167 plasma concentration-time curve from zero to infinity (AUC0-inf) | Day 1 and 8 | |
| Maximum observed plasma concentration (Cmax) of Lu AF11167 | Day 1 and 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the Lu AF36201 plasma concentration-time curve from zero to infinity (AUC0-inf) | Day 1 and 8 | |
| Maximum observed plasma concentration (Cmax) of Lu AF36201 | Day 1 and 8 |
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Inclusion Criteria:
Other pre-defined 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 |
|---|---|---|---|---|---|---|
| Covance | Leeds | United Kingdom |
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| Drug |
|
| ID | Term |
|---|---|
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |
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