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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-004283-61 | EudraCT Number |
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To investigate the relationship between the combined Lu AF35700 and Lu AF36152 plasma concentration and D2 dopamine receptor occupancy up to 172 hours after oral dosing of Lu AF35700
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Lu AF35700 | Experimental |
| |
| Part B: Lu AF35700 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Part A: Lu AF35700 | Drug | One 30 mg single dose for one day; orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Relationship between plasma concentrations and pharmacodynamic (PD) measures specified as binding potential at each scanning time point | Up to 172 hours after dosing | |
| Relationship between plasma concentrations and PD measures specified as plasma concentrations of Lu AF35700, Lu AF36152 and Lu AF35700 + Lu AF36152 at each scanning time point | Up to 172 hours after dosing | |
| Relationship between plasma concentrations and PD measures specified as occupancy in relation to plasma concentrations of Lu AF35700, Lu AF36152 and Lu AF35700 + Lu AF36152, respectively | Up to 172 hours after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Up to Week 12 | |
| Columbia Suicide Severity Rating Scale (C-SSRS) (Part B only) | Up to Week 12 | |
| Area under the curve (AUC), maximum observed concentration (Cmax), oral clearance (CL/F), and apparent elimination half-life (t½) |
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Inclusion 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 |
|---|---|---|---|---|---|---|
| GB801 | London | NW10 7EW | United Kingdom |
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| Part B: Lu AF35700 |
| Drug |
Daily dosing: 10 mg for 3 days, 20 mg for 3 days, 45 mg on Day 7; orally |
|
| Up to 168 hours after dosing |