Healthy Volunteers Clinical Trial
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
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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