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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001738-16 | EudraCT Number |
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The purpose of the study is to see how safe the study drug is and how well it is tolerated after dosing. The study will also investigate how the study drug is taken up, metabolized (chemically broken down), distributed through the body and excreted. A further aim is to look at how this process is possibly altered by food by giving the study drug in the presence and absence of meals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASP7962 | Experimental | Each dose level group will include 8 subjects, of which 6 will be randomized to receive active ASP7962 |
|
| Placebo | Placebo Comparator | Each dose level group will include 8 subjects, of which 2 will be randomized to receive placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP7962 | Drug | Oral |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessed by: clinical laboratory tests, vital signs, Electrocardiogram (ECG), Adverse Events (AEs), real time and continuous cardiac monitoring, orthostatic challenge test, and C-SSRS | Day 1 to End of Study Visit: Routine clinical laboratory tests (hematology, biochemistry [additionally including testosterone, luteinizing hormone {LH}, follicle-stimulating hormone {FSH}, inhibin b, sex hormone-binding globulin {SHBG}] and urinalysis), Vital Signs, ECG, A Es Day 1: Real-time cardiac monitoring Day 1 to Day 2: Continuous cardiac monitoring and orthostatic challenge test Day -1 and End of Study Visit: C-SSRS for suicidality risk | Day -1 through End of Study Visit (7 to 14 days after (early) discharge from the clinical unit (only after the second treatment period for subjects required to return for the food-effect part of the clinical study)) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of ASP7962 in plasma and urine | Measurement of ASP7962 in plasma and urine under fasted and fed conditions. Plasma: AUCinf, AUCinf,u, AUClast, AUClast,u, Cmax, Cmax,u, CL/F, CLu/F, fu, tlag, tmax, t½, Vz/F, Vz,u/F Urine: Aelast, Aeinf, Aelast%, Aeinf%, CLR, CLR,u | Day 1 to Day 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Central Contact | Astellas Pharma Europe B.V. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parexel Early Phase Clinical Unit London | London | HA1 3UJ | United Kingdom |
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| Drug |
Oral |
|