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

NCT04044781 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2022-01-10

No results posted yet for this study

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

DRUG

BPN14770, T2310

Subjects will be administered radio ligand T2310 and BPN14770 to determine brain occupancy of BPN14770.

Sponsors & Collaborators

  • Tetra Discovery Partners

    lead INDUSTRY

Principal Investigators

  • Paul D Mozley, MD · Weill Cornell College of Medicine

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-10
Primary Completion
2020-04-30
Completion
2020-05-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04044781 on ClinicalTrials.gov