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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1168-0766 | Registry Identifier | WHO |
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This phase 1 study will be conducted to examine the degree and duration of brain PDE2A enzyme occupancy /target engagement as a function of TAK-915 plasma concentration in order to guide dosing and schedule for future clinical studies in schizophrenia with TAK-915.
The drug being tested in this study is called TAK-915. TAK-915 is being tested to examine the degree and duration of brain phosphodiesterase 2A (PDE2A) enzyme occupancy/target engagement as a function of TAK-915 plasma concentration in order to guide dosing and schedule for future clinical studies in schizophrenia. This study will look at PDE2A brain enzyme occupancy in the putamen as a function of TAK-915 plasma concentration, as assessed using the positron emission tomography (PET) ligand [18F]MNI-794 after single dosing of TAK-915.
The study will enroll approximately 16 patients in total and within that total, allow up to 5 dose levels and up to 6 subjects per dose level. All participants will receive a single dose of TAK-915 on Day 1. The initial TAK-915 dose level to be studied is 100 mg. Subsequent dose levels may be lower or higher and will be determined through dose level review meetings (DLRMs) following approximately every 2 participants and based on prior occupancy, duration of occupancy, safety, tolerability, and available pharmacokinetic (PK) data.
This single center trial will be conducted in the United States. The overall time to participate in this study is up to 55 days. Participants will make multiple visits to the clinic, and will be contacted by telephone 22 days after last dose of study drug for a follow-up assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAK-915 | Experimental | TAK-915 100 mg suspension, orally, once on Day 1. Additional TAK-915 dose levels may be incorporated based on dose level review meetings (DLRMs) following approximately every 2 participants and based on prior occupancy, duration of occupancy, safety, tolerability, and available pharmacokinetic (PK) data. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-915 | Drug | TAK-915 oral suspension |
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| Measure | Description | Time Frame |
|---|---|---|
| Phosphodiesterase 2A (PDE2A) Brain Enzyme Occupancy in the Putamen as a Function of TAK-915 Plasma Concentration for each subject | Assessed for each subject using the PET ligand [18F]MNI-794 after single dosing of TAK-915, obtained from non-displaceable binding potential (BPnd). | 2 PET scans occurring on Day 1 or 1 PET scan on Day 1 and 1 on Day 2. |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma PK concentrations for each subject post tracer injection for each PET scan period following TAK-915 dosing | t=0, t=45 min and t=90 min (after tracer injection) during each PET scan period. | |
| Dose and exposure of TAK-915 that correspond to PDE2A occupancy in the putamen of at least 45%. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director Clinical Science | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Haven | Connecticut | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 16, 2017 | |
| Reset | Oct 25, 2017 | |
| Release | Jul 2, 2018 | |
| Reset | Dec 28, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 16, 2017 | Oct 25, 2017 | |||
| Jul 2, 2018 |
| ID | Term |
|---|---|
| C000624701 | TAK-915 |
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| At multiple time points (up to 90 minutes after tracer injection) during each PET scan period. |
| Dec 28, 2018 |