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

NCT03030391 | Terminated Phase 1

• 2 other identifiers: 17004117-M-0041
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Camp; Radiation Absorbed Dose; Compartmental Analysis

Outcome Measures

Primary Outcomes (1)

• Quantification of 18F-PF-06445974 binding in brain

  2 hours

Secondary Outcomes (1)

• Biodistribution of 18F-PF-06445974 in the body.

  2 hours

Interventions

PET OTHER

MRI OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older.
• Able to give written informed consent.
• Medically and psychiatrically healthy.
• Enrolled in 01-M-0254 The Evaluation of Participants with Mood and Anxiety Disorders and Healthy Volunteers (PI: Dr. Carlos Zarate).

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.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Muscle Cramp

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Masahiro Fujita, M.D.

  National Institute of Mental Health (NIMH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2017
• First Posted: January 25, 2017
• Study Start: January 10, 2017
• Primary Completion: March 16, 2018
• Study Completion: March 16, 2018
• Last Updated: December 17, 2019

Record last verified: 2018-03-16

Locations

US (1)