Phase 1 TAK-915 Single-Dose Positron Emission Tomography (PET) Occupancy Study
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|ClinicalTrials.gov Identifier: NCT02584569|
Recruitment Status : Completed
First Posted : October 22, 2015
Last Update Posted : July 21, 2016
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Drug: TAK-915||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1, Open-Label, Positron Emission Tomography Study With [18F]MNI-794 to Determine Phosphodiesterase 2A Brain Enzyme Occupancy of TAK-915 After Single-Dose Oral Administration in Healthy Subjects|
|Study Start Date :||November 2015|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||April 2016|
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.
TAK-915 oral suspension
- Phosphodiesterase 2A (PDE2A) Brain Enzyme Occupancy in the Putamen as a Function of TAK-915 Plasma Concentration for each subject [ Time Frame: 2 PET scans occurring on Day 1 or 1 PET scan on Day 1 and 1 on Day 2. ]Assessed for each subject using the PET ligand [18F]MNI-794 after single dosing of TAK-915, obtained from non-displaceable binding potential (BPnd).
- Plasma PK concentrations for each subject post tracer injection for each PET scan period following TAK-915 dosing [ Time Frame: 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%. [ Time Frame: At multiple time points (up to 90 minutes after tracer injection) during each PET scan period. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02584569
|United States, Connecticut|
|New Haven, Connecticut, United States|
|Study Director:||Medical Director Clinical Science||Takeda|