Novel Positron Emission Tomography (PET) Radiotracer to Image Phosphodiesterase-4B (PDE4B)

Stopped early · Phase 1

Conditions studied: Healthy

In brief

Background: The new drug 18F-PF-06445974 has a little radioactivity. This can be seen by a positron emission tomography (PET) scan. The drug helps researchers see a protein, PDE4B, in the brain. Looking at PDE4B in the living brain might show how it is involved in psychiatric and neurological disorders. One part of the study will look at how the study drug is distributed in the brain. Another part will study how brain measures vary. Objectives: To measure the protein PDE4B in the brain. To test how a new radioactive chemical, 18F-PF-06445974, is distributed in the body. Eligibility: Healthy adults ages 18 and older Design: Participants will have 1-3 visits over a year. Each will be 2-5 hours. Women will have a pregnancy test each time.

Key facts

Study ID

NCT03030391

Run by

National Institute of Mental Health (NIMH)

People needed

5

Starts

2017-01-10

Expected to finish

2018-03-16

Last updated by the study team

2019-12-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Any current Axis I diagnosis.
• Clinically significant laboratory abnormalities
• Positive HIV test.
• Unable to have an MRI scan.
• History of neurologic illness or injury with the potential to affect study data interpretation.
• Recent exposure to radiation related to research (i.e. PET from other research) that, when combined with this study, would be above the allowable limits.
• Inability to lie flat on camera bed for at least two hours.
• Pregnancy or breastfeeding.
• Current substance use disorder based on DSM-5.
• Current use of psychiatric medications.
• NIMH employees/staff and their immediate family members will be excluded from the study per NIMH policy.
• Exclusion criteria for the dosimetry subjects are the same as reported above, with the exception of MRI contraindications, because an MRI will not be performed in these subjects.

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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