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Title: Evaluation of a Novel PET Radioligand for Phosphodiesterase-4D (PDE4D)

NCT03861000 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2021-03-22

Study results available
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Summary

Background:

The brain enzyme phosphodiesterase-4D (PDE4D) may affect thinking and depression. Drugs with some radioactivity can attach to enzymes and be seen on a scan. Researchers want to test a new radioactive drug, 11C-T-1650, to measure PDE4D in the brain and body. They also want to see if the new drug BPN14770 blocks 11C-T-1650 from the brain. They want to learn more about psychiatric disorders and possible treatments.

Objectives:

To study how well 11C-T-1650 helps show PDE4D on a scan and to see if BPN14770 blocks it.

Eligibility:

Healthy adults at least 18 years old

Design:

Participants will be screened in other protocols.

Some participants will have 1 body PET scan.

Some participants will have 2 brain PET scans and 1 brain MRI within 1 year.

Some participants (ages 18 55) will:

Have 3 brain PET scans and 1 MRI

Take BPN14770 by mouth twice daily for 3 7 days

Have blood and urine tests

Have a follow-up physical exam and heart test

PET (positron emission tomography) scans will take 2 3 hours. Participants will:

Have a thin plastic tube (catheter) placed in an arm vein by needle.

Get a small amount of 11C-T-1650 injected via catheter. Another catheter may be placed to draw blood.

Lie quietly on a bed that slides into a donut-shaped scanner without sleeping. They may get a short break.

Have heart and vital signs monitored.

Have blood and urine tests.

Learn about drinking fluids and urinating after the scan

MRI (magnetic resonance imagining) scans will take 30 60 minutes:

Participants will lie on a table that slides into a metal cylinder in a magnetic field.

Sponsoring Institute: National Institute of Mental Health

...

Conditions

Interventions

DRUG

[C-11]T-1650

radio-labeled drug

DRUG

BPN14770

selective compound

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    lead NIH

Principal Investigators

  • Robert B Innis, M.D. · National Institute of Mental Health (NIMH)

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2019-03-12
Primary Completion
2020-02-11
Completion
2020-02-11
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT03861000 on ClinicalTrials.gov