Evaluation of (S)-[18F]OF-NB1 as a radioligand for Positron Emission Tomography imaging of GluN2B-NMDA

In this study, we propose to evaluate (S)-[18F]OF-NB1, a NMDAR GluN2B subtype radiotracer labeled with fluorine-18 (18F), to characterize its pharmacokinetic, metabolic and in vivo binding profile. PET imaging with (S)-[18F]OF-NB1 could potentially lead to improvements in the diagnosis and treatment of diseases in which the GluN2B subunit containing NMDARs are implicated (e.g., stroke, Alzheimer's disease, Parkinsons disease, substance use disorder.). This study will enroll up to 18 participants, in the two parts listed below. Part 1 (Dosimetry): Human dosimetry of (S)-[18F]OF-NB1 will be estimated by performing whole-body imaging studies. Up to 6 healthy subjects will be scanned once with (S)-[18F]OF-NB1 to measure the radiation-absorbed doses of each organ per unit of radioactive material administered. Part 2 (Test/Retest): Up to 12 healthy participants will complete two (S)-[18F]OF-NB1 scans, on separate days, to characterize its pharmacokinetic behavior and determine the reliability and reproducibility of in vivo pharmacokinetic parameter measurements. The retest scan will occur within approximately 2 weeks of the test scan, where possible. In the event of cancellations, or scheduling issues, the retest scan may occur up to 12 weeks after the test. In the event the second PET scan is scheduled more than 90 days after the first, the subject would be re-screened to ensure they still meet eligibility. Each subject will also undergo one MRI scan for anatomical identification of brain regions.

Adult male and female subjects, aged 18-60, who are in general good health, meet the inclusion criteria, and who do not meet any of the exclusion criteria will be eligible for enrollment into the study.