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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-003187-39 | EudraCT Number |
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This study will help determine which types of drugs that may interact with Lu AF35700
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lu AF35700 and Cocktail of CYP450 substrates | Experimental | Day 1 oral midazolam administration, Day 2 Cocktail of CYP450 substrates administration. Daily Lu AF35700 administration from Day 5 to Day 28 with co-administration on Day 27 with oral midazolam and Day 28 with CYP450 substrate cocktail |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lu AF35700 | Drug | tablets for oral use, 10 mg/day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUC(0-inf): Area under the plasma concentration-time curve from zero to infinity | Area under the plasma concentration-time curve from zero to infinity for oral midazolam and metabolite and all drug cocktail components and their metabolites | Up to 24 hours post dose on the following days: Day 1 and 27 for oral midazolam. Day 2 and 28 for cocktail components. |
| Cmax: Maximum observed concentration | Maximum observed concentration of oral midazolam and all drug cocktail components and their metabolites | Up to 24 hours post dose on the following days: Day 1 and 27 for oral midazolam. Day 2 and 28 for Cocktail components. |
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Inclusion Criteria:
Exclusion Criteria:
-Pregnant or lactating women
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 Clinical Research Unit Ltd | Leeds | United Kingdom |
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| ID | Term |
|---|---|
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| C000726227 | Lu AF35700 |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Midazolam |
| Drug |
syrup for oral use, 4mg/day |
|
| Cocktail of CYP450 substrates | Drug | Caffeine tablets for oral use, 200 mg/day. Omeprazole tablets for oral use, 40 mg/day. Dextromethorphan tablets for oral use, 30 mg/day. Midazolam IV solution for Intravenous use, 0.025 mg/kg/day |
|
| D006571 | Heterocyclic Compounds |