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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-003302-14 | EudraCT Number |
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This study will investigate the effect of multiple doses of the strong P450 enzyme inhibitor itraconazole on the pharmacokinetics of Lu AF35700 in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lu AF35700 | Experimental | Day 1: Single dose of Lu AF35700. Extensive metabolisers (EMs): 10mg. Poor metabolisers (PMs): 5 mg |
|
| Lu AF35700 AND itraconazole | Experimental | Days 29 to 31: once-daily dosage of 200 mg itraconazole. Day 32: Single dose of Lu AF35700 (EMs: 10 mg, PMs: 5 mg) and 300 mg itraconazole Days 33 to 42: once-daily dosage of 200 mg itraconazole |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lu AF35700 | Drug | Tablets for oral use, single dose in a fasted state. EMs: 10 mg/day, PMs: 5 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC(0-inf) | Area under the Lu AF35700 plasma concentration-time curve (with and without itraconazole) for CYP2D6 EMs | Day 1: Predose to day 29 postdose, Day 32: Predose to day 74 postdose |
| Cmax | Maximum observed plasma concentration of Lu AF35700 (with and without itraconazole) for CYP2D6 EMs | 0-24 hours postdose (Day 1 and day 32) |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol 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 - Dallas | Dallas | Texas | 75247 | United States | ||
| Covance Clinical Research Unit Ltd |
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| ID | Term |
|---|---|
| C000726227 | Lu AF35700 |
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Itraconazole (200 mg) | Drug | 100 mg Capsules for oral use, 200 mg/day. In a fed state |
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| Itraconazole (300 mg) | Drug | 100mg Capsules for oral use, 300 mg/day. In a fasted state. |
|
| Leeds |
| United Kingdom |
| D010879 |
| Piperazines |