NCT04044781

A Phase 1, Open-Label, PET Study of T2310 & BPN14770

A Phase 1, Open-Label, Positron Emission Tomography Study in Healthy Subjects to Determine the Relationship Between Plasma Concentration and Brain Target Occupancy of BPN14770

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Tetra Discovery Partners · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This is a sponsor initiated, single site, first-in-human study of an investigational imaging agent for quantifying the topographically specific concentrations of the phosphodiesterase enzyme Type 4D (PDE4D) with positron emission tomography (PET) using a selective radioligand, \[11C\]T2310. T2310 will be measured with imaging techniques to characterize plasma exposure levels versus regionally specific target engagement fractions for oral doses of BPN14770, an investigational new drug (IND) for modulating PDE4D. BPN14770 is under evaluation for the treatment of Fragile X syndrome and Alzheimer's disease.

Conditions

• To Determine Brain Target Occupancy of BPN14770

Interventions

Type	Name	Description
DRUG	BPN14770, T2310	Subjects will be administered radio ligand T2310 and BPN14770 to determine brain occupancy of BPN14770.

Timeline

• Start date: 2020-01-10
• Primary completion: 2020-04-30
• Completion: 2020-05-30
• First posted: 2019-08-05
• Last updated: 2022-01-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study