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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.
Details
| Lead sponsor | Takeda |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 12 |
| Start date | 2015-11 |
| Completion | 2016-04 |
Conditions
- Healthy Volunteers
Interventions
- TAK-915
Primary outcomes
- Phosphodiesterase 2A (PDE2A) Brain Enzyme Occupancy in the Putamen as a Function of TAK-915 Plasma Concentration for each subject — 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).
Countries
United States